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PD-L1/TGFbetaRII Inhibitor

Anti-PD-L1/TGFbetaRII Fusion Protein M7824 for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Led By Van K Morris
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer immunotherapy to see if it can shrink tumors or help other treatments work better.

Eligible Conditions
  • Colorectal Cancer
  • Rectal Cancer
  • Colon Cancer
  • Microsatellite Instability
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearance of circulating tumor DNA (cohort D)
Objective Response Rate (ORR)
Secondary outcome measures
Adverse Events of Treatment with M7824
Disease-Free Survival (DFS) - cohort D only
Overall Survival (OS)
+1 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (M7824)Experimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,607 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,242 Total Patients Enrolled
Van K MorrisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,530 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Cancer ResearchJournal
Development and Validation of a Gene Signature Classifier for Consensus Molecular Subtyping of Colorectal Carcinoma in a Clia-certified Setting
Morris, Jeffrey S., Rajyalakshmi Luthra, Yusha Liu, Dzifa Y. Duose, Wonyul Lee, Neelima G. Reddy, Justin Windham, et al.. 2021. “Development and Validation of a Gene Signature Classifier for Consensus Molecular Subtyping of Colorectal Carcinoma in a Clia-certified Setting”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-2403.
clinicaltrials.govStudy
M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability
2018. "M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03436563.
All > Rectal Cancer
~10 spots leftby Apr 2025
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