Trial · NCT02408861
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Other | Herpesvirus Loads (Epstein-Barr Virus [EBV], Kaposi Sarcoma Herpes Virus [KSHV], Cytomegalovirus [CMV]) in Plasma | Up to 3 years | Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | Latent Herpesvirus (EBV, KSHV, CMV) in Peripheral Blood Mononuclear Cell (PBMC) | Up to 3 years | Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | Herpesvirus Specific CD8 and CD4 T Cells in PBMC | Up to 3 years | Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | Viral Transcription in Tumor Biopsies (Kaposi Sarcoma Cases) | Up to 3 years | Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | Human Papillomavirus Types in Anal Swabs (Anal Cancer Cases) | Up to 3 years | Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | Latent HIV Loads in PBMC | Up to 3 years | Will be assessed using outgrowth assay. Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
| Other | HIV Reactive T Cells | Up to 3 years | Descriptive statistics will be generated. Changes from pre-study to end of study will be explored using nonparametric Wilcoxon signed-rank test. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT02408861/registered