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NCT03651271 · ClinicalTrials.gov registry record · Phase 2
Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer
A Phase 2 study, sponsored by Parker Institute for Cancer Immunotherapy.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03651271: Completed Phase 2 study, sponsored by Parker Institute for Cancer Immunotherapy.
NCT03651271 is a Phase 2 study that has completed, run by Parker Institute for Cancer Immunotherapy. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651271, a Phase 2 study, has completed, sponsored by Parker Institute for Cancer Immunotherapy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive nivolumab monotherapy, and participants who have a tumor with \< 15% CD8 cells (classified as CD8 low) will receive ipilimumab in combination with nivolumab.
Primary Outcome
CBR is defined as the percentage of participants who show clinical benefit, defined as obtaining a complete response (CR; disappearance of all target and non-target lesions), partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), or stable disease (SD) for ≥ 6 months, as determined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Interventions
- BIOLOGICAL Nivolumab Monotherapy
- BIOLOGICAL Nivolumab and Ipilimumab and Combination for Metastatic Cancer
- BIOLOGICAL Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer
- BIOLOGICAL Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 2 |
What the finished NCT03651271 record still lists
NCT03651271 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab Monotherapy is the first listed.
NCT03651271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03651271 about?
NCT03651271 is a clinical study titled "Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer". This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive niv...
What is the current status of trial NCT03651271?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-10-17. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03651271?
The interventions under investigation include: Nivolumab Monotherapy (BIOLOGICAL), Nivolumab and Ipilimumab and Combination for Metastatic Cancer (BIOLOGICAL), Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer (BIOLOGICAL), Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer (BIOLOGICAL).
Who is sponsoring clinical trial NCT03651271?
This trial is sponsored by Parker Institute for Cancer Immunotherapy, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03651271's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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