Trial · NCT02643303
A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
NCT02643303, Phase 1, Phase 2, Completed, Ludwig Institute for Cancer Research; results first posted 2022-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers. Trials, record NCT02643303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02643303
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
- NCT number
- NCT02643303
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Ludwig Institute for Cancer Research
- Conditions
- Head and Neck Squamous Cell Carcinoma, Breast Cancer, Sarcoma, Merkel Cell Carcinoma, Cutaneous T-Cell Lymphoma, Melanoma, Renal Cancer, Bladder Cancer, Prostate Cancer, Testicular Cancer, Solid Tumor
- Interventions
- Durvalumab, Tremelimumab, Poly-ICLC
- First posted
- 2015-12-31
- Last updated
- 2022-12-02
- Results first posted
- 2022-12-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | up to 15 months | 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. |
| Primary | Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | up to 15 months | 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. |
| Secondary | Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method | up to 15 months | 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). |
| Secondary | Overall Disease Control Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Up to 24 weeks | 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. |
| Secondary | Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | up to 13 months | 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. |
| Secondary | Median PFS by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Estimated Using the Kaplan-Meier Method | Up to 15 months | 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. |
| Secondary | Overall Disease Control Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | up to 24 weeks | 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. Overall Disease Control Rate was defined as the percentage of subjects who had SD for at least 6 months, or PR or CR over a period of at least 4 weeks. Subjects who dropped out prior to meeting the responder criteria were considered non-responders. |
| Secondary | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | up to 5 years | After completion of treatment, all subjects were followed for survival every 3 months for 2 years after completion of treatment; then every 6 months until 5 years from study entry; then yearly until 10 years from study entry. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up were censored on the date when they were last known to be alive. Per protocol amendment 6.0, all post study follow-up for the collection of survival data was discontinued as of February 28, 2022. The last collection of survival data was on February 23, 2022. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | up to 15 months | All subjects who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | up to 15 months | All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method | up to 15 months | All subjects who had at least one dose of study medication. | days | MEDIAN |
| SECONDARY | Overall Disease Control Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Up to 24 weeks | All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | up to 13 months | All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median PFS by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Estimated Using the Kaplan-Meier Method | Up to 15 months | All subjects who had at least one dose of study medication. | days | MEDIAN |
| SECONDARY | Overall Disease Control Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | up to 24 weeks | All subjects who had at least one dose of study medication and one baseline and at least one post-baseline disease assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | up to 5 years | All subjects that had at least one study treatment. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Phase 1, Cohort 1A | Number of Subjects with TEAEs | 4 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Phase 1, Cohort 1B | Number of Subjects with TEAEs | 5 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | Number of Subjects with TEAEs | 1 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | Number of Subjects with TEAEs | 15 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Sarcoma | Number of Subjects with TEAEs | 7 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Merkel Cell Carcinoma | Number of Subjects with TEAEs | 4 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | Number of Subjects with TEAEs | 10 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | Number of Subjects with TEAEs | 3 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | Number of Subjects with TEAEs | 7 | Participants | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Phase 1, Cohort 1A | Number of Subjects with Treatment-Related TEAEs (TRAEs) | 4 | Participants |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1, Cohort 1A | 4 | |
| Overall Study | STARTED | Phase 1, Cohort 1B | 5 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 15 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Sarcoma | 7 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Merkel Cell Carcinoma | 4 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 10 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 3 | |
| Overall Study | STARTED | Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 7 | |
| Overall Study | COMPLETED | Phase 1, Cohort 1A | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,899
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1, Cohort 1A | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1, Cohort 1B | 3 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 2 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Sarcoma | 3 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Merkel Cell Carcinoma | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 3 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 1 | 7 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1, Cohort 1A | 0 | 4 |
1 to 10 of 1,899Source ClinicalTrials.gov
See all 1,899 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1, Cohort 1A | 3 | 4 |
| Total, all-cause mortality | Phase 1, Cohort 1B | 5 | 5 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma | 1 | 1 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer | 9 | 15 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Sarcoma | 6 | 7 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Merkel Cell Carcinoma | 4 | 4 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies | 6 | 10 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases | 3 | 3 |
| Total, all-cause mortality | Cohort 1C + Phase 2; Solid Tumors With Accessible Masses | 6 | 7 |
| Total, other adverse events | Phase 1, Cohort 1A | 4 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19097774 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02643303
GET https://conductscience.org/api/trials/v1/NCT02643303/results?page=2