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About
This phase Ib/II trial studies how well anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) works in treating patients with colorectal cancer (or with other solid tumors with microsatellite instability) that has spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as M7824, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Full description
PRIMARY OBJECTIVES:
-Objective response rate (ORR) in microsatellite instability-high (MSI-H) mCRC patients who have progressed on immune checkpoint blockade therapy (Cohort A).
OR
-ORR in patients with treatment-refractory, consensus molecular subtype 4 (CMS4) mCRC patients coadmnistered SBRT (Cohort B).
OR
SECONDARY OBJECTIVES:
To estimate progression-free survival (PFS) for M7824 in patients with:
-MSI-H mCRC whose disease has progressed on prior immune checkpoint blockade therapy (Cohort A).
OR
-Treatment-refractory, CMS4 mCRC coadministered SBRT (Cohort B). While SBRT is preferred, IMRT or 3D conformal techniques may be utilized at the discretion of the treating radiation oncologist depending on the dose to surrounding normal tissues. Patient will receive a total dose of 24Gy over three days with one of the following modalities, at the discretion of the treating radiation oncologist: SBRT, IMRT and 3D conformal.
OR o MSI-H LA/UR/metastatic non-CRC solid tumors with prior progression on an immune checkpoint blockade therapy (Cohort C).
To estimate overall survival (OS) for M7824 in patients with:
o MSI-H mCRC who are refractory to prior immune checkpoint blockade therapy (Cohort A).
OR o Treatment-refractory, CMS4 mCRC coadministered SBRT (Cohort B). While SBRT is preferred, IMRT or 3D conformal techniques may be utilized at the discretion of the treating radiation oncologist depending on the dose to surrounding normal tissues. Patient will receive a total dose of 24Gy over three days with one of the following modalities, at the discretion of the treating radiation oncologist: SBRT, IMRT and 3D conformal.
OR
To estimate disease-free survival (DFS) in patients with resected mCRC following standard-of-care treatment (cohort D).
To evaluate safety and tolerability of treatment with M7824 in patients with:
o MSI-H mCRC who are refractory to prior immune checkpoint blockade therapy (Cohort A).
OR
EXPLORATORY OBJECTIVES:
OUTLINE:
For cohorts A, B, and C, patients receive M7824 intravenously (IV) over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
For cohort D, patients receive M7824 intravenously (IV) over 1 hour on days 1 and 15 for a total of six treatments.
After completion of study treatment, patients are followed up at 28 days.
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74 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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