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PD-1 Inhibitor

PD-1 Blockade + Chemoradiation for Cancer

Phase 2
Recruiting
Led By Andrea Cercek, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal
Hepatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it, combined with other standard treatments, is effective against a type of solid tumor. The trial will also monitor for side effects.

Who is the study for?
This trial is for adults with advanced solid tumors that lack a certain DNA repair mechanism (dMMR). Participants must be willing to use effective contraception, have no distant metastases, measurable disease, and adequate organ function. Excluded are those with prior treatments for the tumor, active infections or autoimmune diseases, recent major surgeries or vaccines, and known HIV or hepatitis.Check my eligibility
What is being tested?
The study tests TSR-042 (Dostarlimab) followed by standard chemoradiotherapy (capecitabine + IMRT) and surgery in treating dMMR solid tumors. It aims to evaluate the effectiveness of this combination therapy as well as the safety profile of TSR-042.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to PD-1 blockade which can affect organs like lungs or intestines; infusion reactions from Dostarlimab; typical chemotherapy side effects such as nausea and fatigue; radiation therapy may cause skin irritation at treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is functioning properly.
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My tumor shows signs of repair deficiency.
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I am 18 years old or older.
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My blood clotting function is normal.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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My blood clotting tests are normal or managed with medication.
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My cancer is confirmed and has spread locally but not to distant parts.
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I am fully active or can carry out light work.
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I am not pregnant and agree to use birth control during and after the study.
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My organ functions are within normal ranges as required.
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I have been on a stable dose of corticosteroids for at least 4 weeks.
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My cancer has not spread to distant parts of my body.
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I am over 45 and have not had a period for more than a year.
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My blood counts are within normal ranges.
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I have had a hysterectomy, both ovaries removed, or my tubes tied, with documentation.
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My solid tumor is typically treated with therapy before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
The plan is to enroll six patients with MSI, regardless of their primary cancer diagnosis. This cohort will serve to generate hypothesis and initial data to plan a larger study. All analyses from this cohort will be exploratory
Group II: Cohort 1Experimental Treatment3 Interventions
Patients with clinical Stage II or Stage III MRI-staged, MSI-H or dMMR, solid tumors will receive up to 6 months (9, 21-day cycles) of PD-1 blockade followed by radiological and surgical restaging of the tumor. If subject exhibits complete clinical response, non-operative management will be followed. If a complete clinical response is not reached after 6 months of PD-1 blockade, the participant will proceed with standard chemoradiation. After completing chemoradiation participant will be assessed for response if complete CR is not obtained then the participant will proceed with disease specific surgical resection or standard of care therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,489 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,356 Total Patients Enrolled
Andrea Cercek, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,886 Total Patients Enrolled

Media Library

TSR-042 (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04165772 — Phase 2
Rectal Cancer Research Study Groups: Cohort 2, Cohort 1
Rectal Cancer Clinical Trial 2023: TSR-042 Highlights & Side Effects. Trial Name: NCT04165772 — Phase 2
TSR-042 (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04165772 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different places can people participate in this trial?

"There are 11 enrolment sites for this clinical trial, including Lehigh Valley Health Network (Data Collection Only) in Allentown, Pennsylvania, Memorial Sloan Kettering Monmouth - Limited Protocol Activities in Middletown, New jersey and Memoral Sloan Kettering Westchester - Limited Protocol Activities in Harrison, New york."

Answered by AI

Are there any limitations to who can sign up for this particular clinical trial?

"Yes, this research is currently looking for volunteers to participate. The trial was first advertised on December 11th 2019 and has since been updated on October 12th 2020."

Answered by AI

What else is known about TSR-042 from past research?

"TSR-042 was first trialled at Withington Hospital in 2005. So far, 555 completed trials have been conducted. Currently, there are 393 ongoing studies recruiting participants, many of which based in Allentown, Pennsylvania."

Answered by AI

What are the benefits of TSR-042?

"TSR-042 is an effective medication for patients suffering from metastatic colorectal carcinoma, pancreatic endocrine carcinoma, and refractory ovarian cancer."

Answered by AI

Has the FDA cleared TSR-042 for general use?

"Because TSR-042 is only in Phase 2 trials, there is not yet enough data to support its efficacy. However, there is some evidence that suggests it is safe, so it received a score of 2."

Answered by AI

How many people are participating in this clinical trial?

"In order to gather the data required, 51 individuals that meet the pre-determined inclusion criteria are needed to participate. These chosen patients can come from different hospitals, such as Lehigh Valley Health Network (Data Collection Only) in Allentown, Pennsylvania and Memorial Sloan Kettering Monmouth - Limited Protocol Activities in Middletown, New jersey."

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~77 spots leftby Nov 2026