TriangleNCT02643303 · OUTCOME
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- up to 15 months
What was measured
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.
Analysis population: All subjects who received at least one dose of study treatment.
Groups in this outcome
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
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
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
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
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
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
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
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
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
| Group | Source count |
|---|---|
| Phase 1, Cohort 1A | 4 |
| Phase 1, Cohort 1B | 5 |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 15 |
| Cohort 1C + Phase 2; Sarcoma | 7 |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 4 |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 10 |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 3 |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 7 |
Reported measurements
Number of Subjects with TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 7 | Not reported | Not reported | Not reported | Not reported |
Number of Subjects with Treatment-Related TEAEs (TRAEs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 7 | Not reported | Not reported | Not reported | Not reported |
Number of Subjects with Serious TRAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 0 | Not reported | Not reported | Not reported | Not reported |
Number of Subjects with Dose-Limiting Toxicities (DLTs)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 0 | Not reported | Not reported | Not reported | Not reported |
Number of Subjects who Died on Study
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Cohort 1A | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Cohort 1B | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Sarcoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Merkel Cell Carcinoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 7
- title
- Number of Subjects with TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 7
- title
- Number of Subjects with Treatment-Related TEAEs (TRAEs)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Number of Subjects with Serious TRAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Number of Subjects with Dose-Limiting Toxicities (DLTs)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- title
- Number of Subjects who Died on Study
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 7
- units
- Participants
- description
- Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.
- groups
- 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
- OG000
- title
- Phase 1, Cohort 1A
- 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
- OG001
- title
- Phase 1, Cohort 1B
- 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
- OG002
- title
- Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
- 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
- OG003
- title
- Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
- 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
- OG004
- title
- Cohort 1C + Phase 2; Sarcoma
- 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
- OG005
- title
- Cohort 1C + Phase 2; Merkel Cell Carcinoma
- 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
- OG006
- title
- Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
- 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
- OG007
- title
- Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
- 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
- OG008
- title
- Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All subjects who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- up to 15 months
- title
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice