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NCT05286801 · ClinicalTrials.gov registry record · Phase 1
Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors
A Phase 1 study of Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT05286801: Active Phase 1 study of Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT05286801 is a Phase 1 study of Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05286801, a Phase 1 study of Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back (relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, seen with some aggressive cancers that are typically hard to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Frequency (%) of pediatric patients (\<18 years) with cycle 1 dose limiting toxicities attributable to tiragolumab as monotherapy in the safety cohort (Part A).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Atezolizumab
- PROCEDURE Echocardiography Test
- OTHER Fludeoxyglucose F-18
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- UCSF Medical Center-Mission Bay - San Francisco
Illinois
- Lurie Children's Hospital-Chicago - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
- National Institutes of Health Clinical Center - Bethesda
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
- Washington University School of Medicine - St Louis
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2030-03-31 |
| Phase | Phase 1 |
What the registry record for NCT05286801 still lists
NCT05286801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05286801 names 20 study sites across 13 states, led by California, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT05286801 about?
NCT05286801 is a clinical study titled "Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors". This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back (relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the S...
What is the current status of trial NCT05286801?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2022-11-17. Estimated completion is 2030-03-31.
What conditions does trial NCT05286801 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Atypical Teratoid/Rhabdoid Tumor, Epithelioid Sarcoma, Kidney Medullary Carcinoma.
What interventions are being tested in trial NCT05286801?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (BIOLOGICAL), Echocardiography Test (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT05286801?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05286801 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05286801's enrollment target sits among peer trials
86 96th of 176 higher than 81 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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