Trial · NCT02408861
Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
NCT02408861, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2025-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery. Trials, record NCT02408861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02408861
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
- NCT number
- NCT02408861
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 79 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Malignant Solid Neoplasm, Anal Carcinoma, HIV Infection, Kaposi Sarcoma, Lung Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma, Unresectable Solid Neoplasm, HIV-associated Cancers
- Interventions
- Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Ipilimumab, Nivolumab, Positron Emission Tomography
- First posted
- 2015-04-06
- Last updated
- 2026-01-21
- Results first posted
- 2025-09-23
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Nivolumab | Each patient will be evaluated for DLT for the safety evaluation period of 6 weeks | Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least \>= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized. |
| Primary | Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | 6 weeks from the first dose of Nivolumab | Incidence of DLTs during the safety evaluation period of 6 weeks at a given dose from the first dose of treatment. |
| Primary | Incidence of Adverse Events According to NCI CTCAE v5.0 | Participants will be followed for 16 weeks or 112 days after removal from study treatment, or until death, whichever occurs first. | Number of adverse events that are either possibly, probably or definitely attributed to study intervention. In case an adverse event as per the CTCAE v5.0 occurs within a same patient, an instance with the highest severity of the adverse event is counted. Separate event-instances are reported otherwise. |
| Secondary | Objective Response Rate | Up to 3 years | The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma \[cHL\]) and their corresponding 95% confidence intervals (calculated using exact binomial) will be reported separately for solid tumor and cHL according to treatment (combination therapy and single agent) using designated response criteria. Descriptive statistics will also be compiled for duration of response. |
| Secondary | Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks | end of 46 cycles of treatment+ 6 weeks | Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on immune function (CD4 and CD8 cells). Changes in CD4+ T-cell counts, CD8+ T-cell from baseline to end of 46 cycles of treatment+ 6 weeks visit were evaluated by Wilcoxon signed-rank test for paired data. |
| Secondary | Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks | end of 46 cycles of treatment+ 16 weeks | Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on immune function (CD4 and CD8 cells). Changes in CD4+ T-cell counts, CD8+ T-cell from baseline to end of 46 cycles of treatment+ 16 weeks visit were evaluated by Wilcoxon signed-rank test for paired data. |
| Secondary | HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks | end of 46 cycles of treatment+ 6 weeks | Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on HIV viral load. Changes in HIV viral load from baseline to end of 46 cycles of treatment+ 6 weeks visit were evaluated by Wilcoxon signed-rank test for paired data. |
| Secondary | HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks | end of 46 cycles of treatment+16 weeks | Descriptive statistics will be generated to evaluate the effects of single agent nivolumab, and the combination of ipilimumab and nivolumab, on HIV viral load. Changes in HIV viral load from baseline to end of 46 cycles of treatment+ 16 weeks visit were evaluated by Wilcoxon signed-rank test for paired data. |
| Other | Intratumor Immune Cells | Up to 3 years | Will be assessed by immunohistochemistry. Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | Circulating Cytokine Markers | Up to 3 years | Will be assessed by multiplex assay. Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Nivolumab | Each patient will be evaluated for DLT for the safety evaluation period of 6 weeks | Safety evaluable population treated with at least a single dose of Nivolumab. | mg/kg | NUMBER |
| PRIMARY | Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | 6 weeks from the first dose of Nivolumab | Patients evaluated for safety during 6 weeks from the first dose | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Adverse Events According to NCI CTCAE v5.0 | Participants will be followed for 16 weeks or 112 days after removal from study treatment, or until death, whichever occurs first. | Events | NUMBER | |
| SECONDARY | Objective Response Rate | Up to 3 years | Patients exposed to at least a single dose of study drug(s) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks | end of 46 cycles of treatment+ 6 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 6 weeks visit | cells/mm3 | MEDIAN |
| SECONDARY | Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks | end of 46 cycles of treatment+ 16 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 16 weeks visit | cells/mm3 | MEDIAN |
| SECONDARY | HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks | end of 46 cycles of treatment+ 6 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 6 weeks visit | cells/mm3 | MEDIAN |
| SECONDARY | HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks | end of 46 cycles of treatment+16 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 16 weeks visit | cells/mm3 | MEDIAN |
| OTHER_PRE_SPECIFIED | Intratumor Immune Cells | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Circulating Cytokine Markers | Up to 3 years |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Nivolumab | Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) | 3 | mg/kg | ||
| Maximum Tolerated Dose of Nivolumab | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 3 | mg/kg | ||
| Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | Dose De-escalation Nivolumab 3 mg/kg (Stratum 1) | 0 | Participants | ||
| Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 0 | Participants | ||
| Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 1) | 1 | Participants | ||
| Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) | 0 | Participants | ||
| Incidence of Adverse Events According to NCI CTCAE v5.0 | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | Adverse Events | 27 | Events | |
| Incidence of Adverse Events According to NCI CTCAE v5.0 | Dose De-escalation Nivolumab 3mg/kg (Stratum 2) | Adverse Events | 29 | Events | |
| Incidence of Adverse Events According to NCI CTCAE v5.0 | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | Adverse Events | 26 | Events | |
| Incidence of Adverse Events According to NCI CTCAE v5.0 | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 2) | Adverse Events | 8 | Events |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | 6 | |
| Overall Study | STARTED | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 9 | |
| Overall Study | STARTED | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | 7 | |
| Overall Study | STARTED | Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) | 4 | |
| Overall Study | STARTED | Dose Expansion Nivolumab 240 mg q2w in Solid Tumors | 24 | |
| Overall Study | STARTED | Dose Expansion Nivolumab 240 mg q2w and Ipilimumab 1 mg/kg q6w | 20 | |
| Overall Study | STARTED | Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma | 9 | |
| Overall Study | Number of DLTs experienced within 6 weeks | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | 0 | |
| Overall Study | Number of DLTs experienced within 6 weeks | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 0 | |
| Overall Study | Number of DLTs experienced within 6 weeks | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | 1 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,337
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 | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | 1 | 6 | 3 |
| other | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 0 | 9 | 0 |
| other | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | 1 | 7 | 1 |
| other | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) | 0 | 4 | 0 |
| other | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose Expansion Nivolumab 240 mg q2w in Solid Tumors | 3 | 24 | 3 |
| other | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg | 4 | 20 | 8 |
| other | ANEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma | 1 | 9 | 2 |
| other | BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | 0 | 6 | 0 |
| other | BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 0 | 9 | 0 |
| other | BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | 0 | 7 | 0 |
1 to 10 of 1,337Source ClinicalTrials.gov
See all 1,337 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | 0 | 6 |
| Total, all-cause mortality | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 3 | 9 |
| Total, all-cause mortality | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | 1 | 7 |
| Total, all-cause mortality | Dose De-escalation Nivolumab 240 mg and Ipilimumab 1mg/kg (Stratum 2) | 2 | 4 |
| Total, all-cause mortality | Dose Expansion Nivolumab 240 mg q2w in Solid Tumors | 5 | 24 |
| Total, all-cause mortality | Dose Expansion Nivolumab 240 mg and Ipilimumab 1 mg/kg | 1 | 20 |
| Total, all-cause mortality | Nivolumab 240 mg q2w in Classical Hodgkin Lymphoma | 0 | 9 |
| Total, other adverse events | Dose De-escalation Nivolumab 3mg/kg (Stratum 1) | 5 | 6 |
| Total, other adverse events | Dose De-escalation Nivolumab 3 mg/kg (Stratum 2) | 8 | 9 |
| Total, other adverse events | Dose De-escalation Nivolumab 240mg and Ipilimumab 1 mg/kg (Stratum 1) | 6 | 7 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UM1CA121947 | Consortium for Advancing Management and Prevention of Cancer in People with HIV | SPARANO, JOSEPH A. | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2015 to 2025 | NIH RePORTER |
| U01CA121947 | AIDS Malignancy Clinical Trials Consortium (AMC) | MITSUYASU, RONALD T. | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL CANCER INSTITUTE | 2006 to 2014 | NIH RePORTER |
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/NCT02408861
GET https://conductscience.org/api/trials/v1/NCT02408861/results?page=2