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NCT04957615 · ClinicalTrials.gov registry record · Phase 2
Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression
A Phase 2 study of Metastatic Malignant Solid Neoplasm and Unresectable Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04957615: Active Phase 2 study of Metastatic Malignant Solid Neoplasm and Unresectable Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04957615 is a Phase 2 study of Metastatic Malignant Solid Neoplasm and Unresectable Solid Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04957615, a Phase 2 study of Metastatic Malignant Solid Neoplasm and Unresectable Solid Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) with RID1A mutation and CXCL13 expression. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab may help to control the disease.
Primary Outcome
Defined as the rate of confirmed complete responses (CR) + partial responses (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and as assessed by the investigator. Will estimate ORR along with the 95% exact confidence interval (CI)
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What the registry record for NCT04957615 still lists
NCT04957615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT04957615 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04957615 about?
NCT04957615 is a clinical study titled "Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression". This phase II trial studies the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) with RID1A mutation and CXCL13 expression. Immunotherapy with monoclonal antibodies, such as nivolumab, ...
What is the current status of trial NCT04957615?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2021-09-21. Estimated completion is 2027-05-31.
What conditions does trial NCT04957615 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Unresectable Solid Neoplasm.
What interventions are being tested in trial NCT04957615?
The interventions under investigation include: Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04957615?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04957615 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04957615's enrollment target sits among peer trials
16 88th of 92 higher than 5 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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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Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)
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-
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