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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

Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR

Must not have

Active infection requiring systemic therapy

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 tumor shows signs of repair deficiency.

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I am 18 years old or older.

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My kidney function, measured by creatinine or GFR, is within the normal range.

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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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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 solid tumor is typically treated with therapy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for an infection.

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I have not had major surgery or a significant injury in the last 28 days.

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I have a history of lung scarring or fibrosis.

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I haven't taken high-dose steroids or immunosuppressants in the last 7 days.

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I have had radiation, chemotherapy, or surgery for my tumor.

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I have not received a live vaccine in the last 30 days.

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I have an autoimmune disease that needed strong medication in the last 2 years.

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I am not currently on any other cancer treatments or experimental drugs.

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I had a severe reaction to previous immunotherapy, except for minor lab changes.

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I have been diagnosed with HIV.

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My cancer has spread or come back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 20Eligibility criteria met