Actively Recruiting
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-13
212
Participants Needed
10
Research Sites
363 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
T
Tesaro, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial.
- Age 18 years or older at consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed locally advanced solid tumor or endometrial cancer (specific cohorts).
- Tumors typically treated with neoadjuvant therapy or surgery.
- Endometrial cancer at FIGO 2009 Stage I or II (Cohort 3).
- No evidence of distant metastases.
- Measurable or clinically evaluable disease.
- Tumor specimen shows mismatch repair deficiency by immunohistochemistry or microsatellite instability.
- Negative pregnancy test for women of childbearing potential within 72 hours before treatment.
- Willingness to use effective contraception during study and 150 days after last dose if of childbearing potential.
- Non-childbearing potential defined by age, menopausal status, or surgical sterilization.
- Stable corticosteroid dose for at least 4 weeks before starting treatment.
- QTcF ≤ 450 msec, or ≤ 480 msec with bundle branch block.
- Adequate organ function within 14 days before treatment start (hematological, renal, hepatic, coagulation).
You will not qualify if you...
- Presence of metastatic or recurrent disease.
- Prior radiation, chemotherapy, or surgery for the tumor (except prior hormonal therapy for Cohort 3 with 1 week washout).
- For colorectal primary tumors: symptomatic bowel obstruction (temporary diverting ostomy allowed).
- Other invasive malignancy within 5 years (Cohort 1), except certain skin or cervical cancers.
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before treatment.
- Active autoimmune disease requiring systemic treatment within 2 years or severe autoimmune history.
- Active infection needing systemic therapy.
- Prior therapy targeting T-cell co-stimulation or checkpoint pathways (Cohorts 1 & 3).
- Grade ≥3 immune-related adverse events with prior immunotherapy (except minor lab abnormalities).
- Use of other anticancer or experimental therapies during study treatment.
- Known HIV infection.
- Active Hepatitis B or C infection.
- Pregnant or breastfeeding women, or men planning to father children during study and 150 days after last dose.
- Medical or psychiatric conditions that make participation inappropriate.
- Live vaccine within 30 days of starting study medication.
- Major surgery, open biopsy, or major injury within 28 days before enrollment (except endometrial sampling for Cohort 3).
- History of interstitial lung disease.
- Known allergy to TSR-042 or its components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Hartford Healthcare (Data Collection)
Hartford, Connecticut, United States, 06102
Actively Recruiting
2
Baptist Alliance MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth - Limited Protocol Activities
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen - Limited Protocol Activities
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Commack - Limited Protocol Activities
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester - Limited Protocol Activities
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau - Limited Protocol Activities
Uniondale, New York, United States, 11553
Actively Recruiting
10
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
Research Team
A
Andrea Cercek, MD
CONTACT
N
Neil Segal, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here