M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03436563|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : January 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|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||Biological: Anti-PD-L1/TGFbetaRII Fusion Protein M7824||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Trial of M7824 in Solid Tumors With Microsatellite Instability With Consensus Molecular Subtype 4 Metastatic Colorectal Cancer in Combination With Radiation, or in Colorectal Cancer Patients With Detectable Circulating Tumor DNA Following Definitive Therapy|
|Actual Study Start Date :||March 7, 2018|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Treatment (M7824)
Patients receive M7824 IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity (Cohorts A,B, and C) or for six doses in patients with detectable circulating tumor DNA (ctDNA) following resection of all known liver metastases (Cohort D).
Biological: Anti-PD-L1/TGFbetaRII Fusion Protein M7824
- Objective Response Rate (ORR) [ Time Frame: Baseline up to 12 months ]ORR confirmed according to RECIST 1.1 (cohorts A, B, C)
- Clearance of circulating tumor DNA (cohort D) [ Time Frame: Baseline up to 12 weeks ]Clearance of circulating tumor DNA (cohort D)
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2 years ]PFS determined according to RECIST 1.1.
- Overall Survival (OS) [ Time Frame: Baseline up to 2 years ]
- Adverse Events of Treatment with M7824 [ Time Frame: Start of study treatment up to 28 days after end of treatment ]Adverse events confirmed per NCI-CTCAE v4.03.
- Disease-Free Survival (DFS) - cohort D only [ Time Frame: Baseline up to 2 years ]DFS according to RECIST 1.1 criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436563
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Van K Morris||M.D. Anderson Cancer Center|