TriangleNCT02643303 · STUDY IN CONTEXT
A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression did not occur. Per irRECIST, Progressive Disease (irPD) was defined as a ≥ 20% increase from nadir in the Total Measured Tumor Burden (TMTB).
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria. Overall Disease Control Rate was defined as the percentage of subjects who had irSD for at least 6 months, or irPR or irCR over a period of at least 4 weeks. Subjects who dropped out prior to meeting the responder criteria were considered non-responders.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; Stable Disease (SD): small changes that did not meet above criteria.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression did not occur. Per RECIST 1.1, Progressive disease (PD) was defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- trial label
- A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 9
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- source section id
- NCT02643303-om-0000
- source outcome index
- 0
- endpoint
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
- endpoint definition
- 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.
- time origin
- up to 15 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects who received at least one dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0001
- source section id
- NCT02643303-om-0001
- source outcome index
- 1
- endpoint
- Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- endpoint definition
- Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measured Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria.
- time origin
- up to 15 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0002
- source section id
- NCT02643303-om-0002
- source outcome index
- 2
- endpoint
- Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method
- endpoint definition
- Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression did not occur. Per irRECIST, Progressive Disease (irPD) was defined as a ≥ 20% increase from nadir in the Total Measured Tumor Burden (TMTB).
- time origin
- up to 15 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects who had at least one dose of study medication.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0003
- source section id
- NCT02643303-om-0003
- source outcome index
- 3
- endpoint
- Overall Disease Control Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- endpoint definition
- Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per irRECIST, measurable lesions were categorized as follows: Complete Response (irCR): Complete disappearance of all target lesions; Partial Response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); Progressive Disease (irPD): ≥ 20% increase from nadir in Total Measured Tumor Burden (TMTB); Stable Disease (irSD): not meeting above criteria. Overall Disease Control Rate was defined as the percentage of subjects who had irSD for at least 6 months, or irPR or irCR over a period of at least 4 weeks. Subjects who dropped out prior to meeting the responder criteria were considered non-responders.
- time origin
- Up to 24 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0004
- source section id
- NCT02643303-om-0004
- source outcome index
- 4
- endpoint
- Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- endpoint definition
- Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions or presence of new lesions; Stable Disease (SD): small changes that did not meet above criteria.
- time origin
- up to 13 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0005
- source section id
- NCT02643303-om-0005
- source outcome index
- 5
- endpoint
- Median PFS by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Estimated Using the Kaplan-Meier Method
- endpoint definition
- Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 21 days before the first dose of study treatment), and in Cycles 4, 7, 9 and 11, when a subject discontinued treatment prematurely and 28 days after the last dose of study treatment. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression did not occur. Per RECIST 1.1, Progressive disease (PD) was defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the presence of new lesions.
- time origin
- Up to 15 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All subjects who had at least one dose of study medication.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase 1, Cohort 1A
- regimen
- 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
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Phase 1, Cohort 1B
- regimen
- 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
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
- regimen
- 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
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
- regimen
- 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
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Cohort 1C + Phase 2; Sarcoma
- regimen
- 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
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Cohort 1C + Phase 2; Merkel Cell Carcinoma
- regimen
- 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
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
- regimen
- 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
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
- regimen
- 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
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
- regimen
- 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
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase 1, Cohort 1A
- regimen
- 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
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase 1, Cohort 1B
- regimen
- 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
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
- regimen
- 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
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02643303-om-0001#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG000
- source section id
- NCT02643303-ae
- event group key
- EG000
- event group label
- Phase 1, Cohort 1A
- serious affected
- 0
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG001
- source section id
- NCT02643303-ae
- event group key
- EG001
- event group label
- Phase 1, Cohort 1B
- serious affected
- 3
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG002
- source section id
- NCT02643303-ae
- event group key
- EG002
- event group label
- Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG003
- source section id
- NCT02643303-ae
- event group key
- EG003
- event group label
- Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
- serious affected
- 4
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG004
- source section id
- NCT02643303-ae
- event group key
- EG004
- event group label
- Cohort 1C + Phase 2; Sarcoma
- serious affected
- 3
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG005
- source section id
- NCT02643303-ae
- event group key
- EG005
- event group label
- Cohort 1C + Phase 2; Merkel Cell Carcinoma
- serious affected
- 2
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG006
- source section id
- NCT02643303-ae
- event group key
- EG006
- event group label
- Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
- serious affected
- 3
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG007
- source section id
- NCT02643303-ae
- event group key
- EG007
- event group label
- Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-testicular-cancer
- nct id
- NCT02643303
- harm key
- EG008
- source section id
- NCT02643303-ae
- event group key
- EG008
- event group label
- Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
- serious affected
- 2
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 0
- collection period
- 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.
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice