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NCT04266912 · ClinicalTrials.gov registry record · Phase 1
Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04266912: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04266912 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 23 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04266912, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of avelumab with M6620 in treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). DDR deficiency refers to a decrease in the ability of cells to respond to damaged DNA and to repair the damage, which can be caused by genetic mutations. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab together with M6620 may help to control DDR deficient metastatic or unresectable solid tumors.
Primary Outcome
A DLT was evaluated according to the NCI CTCAE 5.0 \& defined as: grade 4 neutropenia lasting greater than 7 days or febrile neutropenia, grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia lasting greater than 7 days, any treatment related adverse event that in the opinion of the safety monitoring committee exposes participants to unacceptable risk, a delay of more than 4 weeks before receiving the next scheduled study drug due to persisting toxicities attributable to study drugs
Conditions Studied
Interventions
- DRUG Avelumab
- DRUG Berzosertib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-03-17 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04266912 still lists
NCT04266912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Avelumab is the first listed.
NCT04266912 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04266912 about?
NCT04266912 is a clinical study titled "Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors". This phase I/II trial studies the side effects and best dose of avelumab with M6620 in treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). DDR deficienc...
What is the current status of trial NCT04266912?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-03-17. Estimated completion is 2025-12-31.
What conditions does trial NCT04266912 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm.
What interventions are being tested in trial NCT04266912?
The interventions under investigation include: Avelumab (DRUG), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT04266912?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04266912 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
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Where NCT04266912's enrollment target sits among peer trials
23 84th of 92 higher than 9 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.
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