Anti-PD-1 +/- RT for MSI-H Solid Tumors

Withdrawn before enrolling · Phase 2

Conditions studied: Microsatellite Instability High, Mismatch Repair Deficiency, Colorectal Cancer

In brief

To determine if the out-of-field ORR is improved with the addition of radiation therapy to anti-PD-1 for patients with MSI-H/dMMR metastatic solid tumors. Determine the rates of in-field tumor control, disease control (stable disease, partial response, complete response), durability of disease response, progression-free survival, overall survival, and to assess quality of life and toxicity. Determine the chronology and profile of the radiation-associated immune response.

Key facts

Study ID

NCT04001101

Run by

University of Colorado, Denver

People needed

0

Starts

2019-10-10

Expected to finish

2021-11-17

Last updated by the study team

2021-11-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Adult patients, 18-100 years of age.
• ECOG 0 or 1.
• Unresectable or metastatic MSI-H/dMMR tumors eligible to receive pembrolizumab according to FDA-approved indications:
• Solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR
• Colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan11
• Confirmation from medical or gynecologic oncology that the patient is eligible to receive pembrolizumab per FDA-approved indication for patients not currently receiving pembrolizumab .
• At least one site of disease amenable to radiation therapy per the acceptable dosing regimens outlined in section 6.2, and at least one additional site of measurable disease suitable for out-of-field response assessment.
• Adequate baseline labs for initiation of trial treatment:
• absolute neutrophil count (ANC) >1,000/µL
• platelets >75,000/µL
• hemoglobin >8 g/dL
• serum creatinine < 1.5 x ULN
• serum total bilirubin < 1.5 x ULN
• AST and ALT < 2.5 x ULN, or < 5 x ULN if liver metastasis are present

You may not qualify if…

• Pregnant women. Pregnancy testing is required for all female subjects of childbearing potential.
• Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI.
• History of immunodeficiency, hypersensitivity to pembrolizumab, or other medical contraindication to receipt of pembrolizumab.
• Active infection.
• Active CNS metastases. Patients with treated CNS metastases are eligible.
• Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years.

Where it is running

• University of Colorado Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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