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M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability

NCT03436563 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-11-27

Study results available
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Summary

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.

Conditions

  • Colon Adenocarcinoma
  • High-Frequency Microsatellite Instability
  • Metastatic Malignant Solid Neoplasm
  • Rectal Adenocarcinoma
  • Refractory Colorectal Carcinoma
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Rectal Cancer AJCC v8
  • Stage IVA Colon Cancer AJCC v8
  • Stage IVA Rectal Cancer AJCC v8
  • Stage IVB Colon Cancer AJCC v8
  • Stage IVB Rectal Cancer AJCC v8

Interventions

BIOLOGICAL

Anti-PD-L1/TGFbetaRII Fusion Protein M7824

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Van K Morris, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2023-08-08
Completion
2023-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03436563 on ClinicalTrials.gov