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NCT02408861 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 1
Development phase
79
Enrollment target

NCT02408861: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT02408861 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02408861, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
79 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory), or solid tumors that have spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of the immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone.

Primary Outcome

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2015-10-21
Est. Completion 2024-08-31
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

Why NCT02408861 stopped before completion

NCT02408861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).

The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02408861 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02408861 about?

NCT02408861 is a clinical study titled "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". This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory...

What is the current status of trial NCT02408861?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2015-10-21. Estimated completion is 2024-08-31.

What interventions are being tested in trial NCT02408861?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02408861?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02408861's enrollment target sits among peer trials

79 696th of 2000 higher than 1,304 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT02408861, the US trial registry maintained by the National Library of Medicine. NCT02408861 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.