Trials / Recruiting
RecruitingNCT04165772
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.
Conditions
- Rectal Adenocarcinoma
- Clinical Stage: Stage II (T3-4, N-)
- Stage III (Any T, N+)
- Solid Tumor
- Solid Tumor, Adult
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TSR-042 or Dostarlimab | Patients will be given TSR-042/Dostarlimab at a dose of 500mg IV, over 30 minutes Q 3 weeks. |
| DRUG | capecitabine or 5-FU | Capecitabine 825mg/m2 BID concurrently with radiation per standard radiation guidelines. If patient is unable to tolerate oral medication, infusional 5-FU is an acceptable alternative. |
| RADIATION | Intensity Modulated Radiation Therapy (IMRT) | The radiation dose is 5400 cGy to the tumor and surrounding nodes 4700 cGy to the pelvis, with an integrated boost to the primary tumor and involved nodes of receiving 5400cGy in 27fx. |
Timeline
- Start date
- 2019-12-11
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
- First posted
- 2019-11-18
- Last updated
- 2026-01-23
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04165772. Inclusion in this directory is not an endorsement.