RecruitingPhase 2interventionalRules rewrite

Phase 2: testing TSR-042 or Dostarlimab for Rectal Adenocarcinoma

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT04165772 · Memorial Sloan Kettering Cancer Center · enrollment listed as 212

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TSR-042 or Dostarlimab, capecitabine or 5-FU, or Intensity Modulated Radiation Therapy (IMRT). The registry lists allocation as randomized. This study wants 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.

They plan to enroll about 212 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

Interventions: TSR-042 or Dostarlimab, capecitabine or 5-FU, Intensity Modulated Radiation Therapy (IMRT)

Primary outcome (registry wording): Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months

Who it is for (from inclusion criteria)

Ages 18 Years to any
how well you can do daily activities (ECOG score) of 0 or 1
Histologically confirmed locally advanced solid tumor (Cohorts 1 \& 2)
Histologically confirmed endometrial cancer (Cohort 3)
Solid tumors that in standard practice would be treated with neoadjuvant therapy or surgery (depending on tumor type) (Cohorts 1 \& 2)
Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3)
No evidence of distant metastases
Radiologically measurable or clinically evaluable disease

Who the registry excludes

Presence of metastatic or recurrent disease
Prior radiation therapy, chemotherapy, or surgery for tumor
a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for treatment of endometrial hyperplasia and/or endometrial cancer. Hormonal therapy must be discontinued at least 1-week prior to first dose of study treatment (dostarlimab)
For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible)
Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment
Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses

Public study contact (from the registry)

Andrea Cercek, MD

646-888-4189

cerceka@mskcc.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

10 listed

Hartford Healthcare (Data Collection) — Hartford, Connecticut (recruiting)
Baptist Alliance MCI (Data Collection Only) — Miami, Florida (recruiting)
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities — Basking Ridge, New Jersey (recruiting)
Memorial Sloan Kettering Monmouth - Limited Protocol Activities — Middletown, New Jersey (recruiting)
Memorial Sloan Kettering Bergen - Limited Protocol Activities — Montvale, New Jersey (recruiting)
Memorial Sloan Kettering Commack - Limited Protocol Activities — Commack, New York (recruiting)
Memorial Sloan Kettering Westchester - Limited Protocol Activities — Harrison, New York (recruiting)
Memorial Sloan Kettering Cancer Center — New York, New York (recruiting)
Memorial Sloan Kettering Nassau - Limited Protocol Activities — Uniondale, New York (recruiting)
Lehigh Valley Health Network (Data Collection Only) — Allentown, Pennsylvania (recruiting)

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FAQ about this NCT record

Is NCT04165772 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04165772?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04165772?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary