CLINICAL TRIALS PROFILE FOR COMMIT

All Clinical Trials for Commit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000895 ↗	A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to determine if infection with Mycobacterium avium complex (MAC) occurs in other parts of the body before it is found in the blood. This study also evaluates the relationships between the amount of HIV in the blood, immune system functions, and the presence of MAC infection. HIV-positive patients are at risk for MAC infection because their immune systems have been weakened by HIV. It is hoped that aggressive treatment with anti-HIV drugs may improve their immune systems enough to prevent against MAC.
NCT00074737 ↗	Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML	Completed	Eleos, Inc.	Phase 2	2004-04-01	The principal goal of this clinical trial is to assess the ability of cenersen sodium (EL625) to improve cancer responsiveness to the established AML therapeutic agent Idarubicin used alone or in combination with Cytarabine (Ara-C). Cenersen sodium is a drug that is designed to block the effects of a protein called p53. Laboratory evidence shows that blocking p53 will make many types of cancer, including acute myelogenous leukemia (AML), more sensitive to a variety of established cancer therapeutics while making normal tissues more resistant to the toxic effects of these agents.
NCT00132899 ↗	COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)	Completed	Schering-Plough	Phase 3	2005-12-01	The primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD) in patients with symptoms that are persistent enough to require corticosteroid therapy.

Clinical Trial Conditions for Commit

Condition Name

Condition Name for Commit
Intervention	Trials
Diabetes Mellitus	12
Depression	2
Tobacco Use Disorder	2

Condition MeSH

Condition MeSH for Commit
Intervention	Trials
Diabetes Mellitus	13
Disease	3
Tobacco Use Disorder	3

Clinical Trial Locations for Commit

Trials by Country

Trials by Country for Commit
Location	Trials
United States	272
United Kingdom	7
South Africa	6
Brazil	5
Mexico	5

Trials by US State

Trials by US State for Commit
Location	Trials
Texas	12
Florida	12
California	12
South Carolina	11
Pennsylvania	11

Clinical Trial Progress for Commit

Clinical Trial Phase

Clinical Trial Phase for Commit
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	12
Phase 2	9

Clinical Trial Status

Clinical Trial Status for Commit
Clinical Trial Phase	Trials
Completed	26
Recruiting	5
Terminated	3

Clinical Trial Sponsors for Commit

Sponsor Name

Sponsor Name for Commit
Sponsor	Trials
Takeda	13
National Cancer Institute (NCI)	3
National Institute on Drug Abuse (NIDA)	2

Sponsor Type

Sponsor Type for Commit
Sponsor	Trials
Other	37
Industry	25
NIH	9

Clinical Trials Update, Market Analysis, and Projections for the COMMIT Study

Introduction to the COMMIT Study

The COMMIT Study (NRG-GI004/SWOG S1610) is a significant ongoing clinical trial within the NRG Oncology gastrointestinal portfolio of clinical trials. This study focuses on patients with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR) metastatic colorectal cancer, a subgroup representing about 5% of the metastatic colorectal cancer population[1].

Background and Rationale

The COMMIT Study was created to address the limitations of current treatments for MSI-H/dMMR metastatic colorectal cancer. While immunotherapy has shown benefits in this subgroup, nearly half of the patients treated with immunotherapy alone experience cancer progression within the first year. The study aims to improve these outcomes by evaluating the combination of immunotherapy (atezolizumab) with anti-angiogenesis (bevacizumab) and chemotherapy (mFOLFOX6)[1].

Study Design and Treatments

The COMMIT Study is designed to compare the efficacy of combining atezolizumab with the mFOLFOX6/bevacizumab regimen against atezolizumab as a single agent. The trial will assess whether the addition of mFOLFOX6/bevacizumab to atezolizumab improves survival, progression-free survival, and response rates compared to atezolizumab alone. It will also evaluate potential toxicities associated with the combination therapy[1].

Comparison with Other Trials

The COMMIT Study is often compared to the ATOMIC (A021502) Trial, which also focuses on patients with dMMR/MSI-H colorectal cancer but in the stage III setting. While ATOMIC investigates the addition of atezolizumab to FOLFOX in the adjuvant setting, COMMIT examines the addition of atezolizumab to FOLFOX plus bevacizumab in the metastatic setting. Both trials are phase III and aim to improve clinically important outcomes, potentially leading to changes in the standard of care for these patients[1].

Current Status and Amendments

The COMMIT Study has recently surpassed the milestone of enrolling its 100th patient out of a planned 120 patients. Recent amendments to the study protocol have been made to better reflect real-world practice, including more liberal eligibility criteria such as allowing one cycle of FOLFOX plus bevacizumab prior to study enrollment and more flexible hepatic and renal function allowances. These changes are expected to increase patient accrual and generalizability without compromising safety[1].

Market Analysis of Clinical Trials

The global clinical trials market is experiencing significant growth, driven by the increasing prevalence of chronic diseases such as cancer and cardiovascular disorders. The market was valued at USD 84.61 billion in 2024 and is projected to reach USD 146.60 billion by 2033, growing at a CAGR of 6.07% during the forecast period (2025–2033)[3].

Impact of Chronic Diseases on Clinical Trials

Chronic diseases, including cancer, are major drivers of the clinical trials market. According to the World Health Organization (WHO), chronic diseases account for 74% of all global mortalities, leading to a surge in demand for innovative treatments and clinical trials. The COMMIT Study, focusing on a specific subgroup of colorectal cancer patients, is part of this broader trend towards personalized and effective treatments[3].

Compliance and Reporting in Clinical Trials

The timely reporting of clinical trial results is crucial for advancing medical knowledge and improving patient care. The NIH has implemented policies to ensure compliance with results submission to ClinicalTrials.gov. As of recent analyses, 96% of NIH-grant-funded clinical trials had results information submitted, although only 37% submitted on time. Ensuring timely and complete reporting is essential for the integrity and utility of clinical trials like the COMMIT Study[4].

Projections and Future Implications

The COMMIT Study has the potential to significantly impact the management of MSI-H/dMMR metastatic colorectal cancer. If the combination therapy proves superior to single-agent immunotherapy, it could lead to a change in the standard of care for this patient population. The study's findings, combined with those from the ATOMIC trial, will contribute to a better understanding of treatment mechanisms and resistance, ultimately leading to more personalized treatment strategies.

Key Takeaways

• Study Focus: The COMMIT Study investigates the combination of atezolizumab with mFOLFOX6/bevacizumab for MSI-H/dMMR metastatic colorectal cancer.
• Design and Treatments: The study compares the combination therapy against atezolizumab alone to assess survival, progression-free survival, and response rates.
• Market Context: The global clinical trials market is growing, driven by the need for innovative treatments for chronic diseases.
• Compliance: Timely reporting of clinical trial results is crucial for advancing medical knowledge and improving patient care.
• Future Implications: The study's findings could lead to changes in the standard of care for MSI-H/dMMR metastatic colorectal cancer and contribute to personalized treatment strategies.

FAQs

Q1: What is the primary focus of the COMMIT Study? The COMMIT Study focuses on evaluating the efficacy of combining atezolizumab with the mFOLFOX6/bevacizumab regimen for patients with MSI-H/dMMR metastatic colorectal cancer.

Q2: How does the COMMIT Study compare to the ATOMIC Trial? Both trials investigate the addition of atezolizumab to standard treatment regimens but differ in the stage of disease (stage III for ATOMIC and stage IV for COMMIT) and the inclusion of bevacizumab in the COMMIT Study.

Q3: What are the recent amendments to the COMMIT Study protocol? Recent amendments include more liberal eligibility criteria, such as allowing one cycle of FOLFOX plus bevacizumab prior to enrollment and more flexible hepatic and renal function allowances.

Q4: What is the current status of patient enrollment in the COMMIT Study? The study has recently surpassed the milestone of enrolling its 100th patient out of a planned 120 patients.

Q5: How does the COMMIT Study fit into the broader context of the clinical trials market? The COMMIT Study is part of the growing global clinical trials market, driven by the increasing prevalence of chronic diseases and the need for innovative treatments.

Sources

1. NRG Oncology: NRG-GI004/SWOG S1610: The COMMIT Study - NRG Oncology.
2. Brookings Institution: The dynamics of US drug markets.
3. Straits Research: Global Clinical Trials Market Size, Top Share, Trends, Forecast by ...
4. NIH: NIH Clinical Trials Reporting Compliance: A Shared Commitment.