NCT02643303 · ADVERSE EVENTS

Adverse events

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers · Source last updated 2022-12-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years.
Other-event reporting threshold: 0%

AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1, Cohort 1A Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC	0 / 4	4 / 4	3 / 4
Phase 1, Cohort 1B Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	3 / 5	5 / 5	5 / 5
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	0 / 1	1 / 1	1 / 1
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	4 / 15	15 / 15	9 / 15
Cohort 1C + Phase 2; Sarcoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	3 / 7	7 / 7	6 / 7
Cohort 1C + Phase 2; Merkel Cell Carcinoma Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	2 / 4	4 / 4	4 / 4
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	3 / 10	10 / 10	6 / 10
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	2 / 3	3 / 3	3 / 3
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC	2 / 7	7 / 7	6 / 7

Group identifiers: EG000: Phase 1, Cohort 1A · EG001: Phase 1, Cohort 1B · EG002: Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma · EG003: Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer · EG004: Cohort 1C + Phase 2; Sarcoma · EG005: Cohort 1C + Phase 2; Merkel Cell Carcinoma · EG006: Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies · EG007: Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases · EG008: Cohort 1C + Phase 2; Solid Tumors With Accessible Masses

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Eyelid ptosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
7
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Pneumonia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
2
num At Risk
15
group Id
EG004
num Affected
3
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
2
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
2
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Excess cerumen production
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
7
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Eye swelling

Complete source fields

description

event Groups

deaths Num Affected
3
deaths Num At Risk
4
description
Subjects received durvalumab (1500 mg IV every 4 weeks \[Q4W\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Poly-ICLC
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Phase 1, Cohort 1A
deaths Num Affected
5
deaths Num At Risk
5
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Phase 1, Cohort 1B
deaths Num Affected
1
deaths Num At Risk
1
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG002
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
deaths Num Affected
9
deaths Num At Risk
15
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG003
other Num Affected
15
other Num At Risk
15
serious Num Affected
4
serious Num At Risk
15
title
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
deaths Num Affected
6
deaths Num At Risk
7
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG004
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Cohort 1C + Phase 2; Sarcoma
deaths Num Affected
4
deaths Num At Risk
4
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG005
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Cohort 1C + Phase 2; Merkel Cell Carcinoma
deaths Num Affected
6
deaths Num At Risk
10
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
3
serious Num At Risk
10
title
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
deaths Num Affected
3
deaths Num At Risk
3
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
deaths Num Affected
6
deaths Num At Risk
7
description
Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4. Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3. Durvalumab Tremelimumab Poly-ICLC
id
EG008
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
2
num At Risk
15
group Id
EG004
num Affected
3
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
3
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
2
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
1
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
2
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Excess cerumen production
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
7
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Eye swelling

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Eyelid ptosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
2
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
1
num At Risk
7
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
1
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
1
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
1
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
0
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
2
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
5
group Id
EG002
num Affected
0
num At Risk
1
group Id
EG003
num Affected
1
num At Risk
15
group Id
EG004
num Affected
0
num At Risk
7
group Id
EG005
num Affected
0
num At Risk
4
group Id
EG006
num Affected
0
num At Risk
10
group Id
EG007
num Affected
0
num At Risk
3
group Id
EG008
num Affected
0
num At Risk
7
term
Pneumonia

time Frame

All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of the causal relationship to study drug). AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). All-cause mortality includes all deaths which were reported up to 5 years.

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Preserved source evidence · Not medical advice