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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04165772
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clinical Stage: Stage II (T3-4, N-)
  • Rectal Adenocarcinoma
  • Solid Tumor
  • Solid Tumor, Adult
  • Stage III (Any T, N+)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TSR-042 or Dostarlimab — DRUG
    Patients will be given TSR-042/Dostarlimab at a dose of 500mg IV, over 30 minutes Q 3 weeks.
  • capecitabine or 5-FU — DRUG
    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.
  • Intensity Modulated Radiation Therapy (IMRT) — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Dec 11, 2019
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
212 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    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.
  • Other: Cohort 2
    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
  • Other: Cohort 3
    Participants with FIGO Stage I or II mismatch repair deficient (MMRd) and/or microsatellite instability high (MSI-H) endometrial cancer will receive intravenous dostarlimab.

Primary Outcome Measure

Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Hartford Healthcare (Data Collection)HartfordConnecticut06102
Gerard Fumo, DO
860-972-4700
Baptist Alliance MCI (Data Collection Only)MiamiFlorida33143
Antonio Ucar, MD
786-373-3436
Memorial Sloan Kettering Basking Ridge - Limited Protocol ActivitiesBasking RidgeNew Jersey07920
Andrea Cercek, MD
646-888-4189
Andrea Cercek, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Monmouth - Limited Protocol ActivitiesMiddletownNew Jersey07748
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Bergen - Limited Protocol ActivitiesMontvaleNew Jersey07645
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Commack - Limited Protocol ActivitiesCommackNew York11725
Andrea Cercek, MD
646-888-4189
Andera Cercek, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Westchester - Limited Protocol ActivitiesHarrisonNew York10604
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Andrea Cercek, MD
646-888-4189
Leonard Saltz, MD
646-888-4181
Andrea Cercek, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau - Limited Protocol ActivitiesUniondaleNew York11553
Andrea Cercek, MD
646-888-4189
Lehigh Valley Health Network (Data Collection Only)AllentownPennsylvania18103
Maged Khalil, MD
610-402-7880

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