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A Randomized, Open-label, Study of CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Patients With Melanoma

This study is evaluating CMP-001 in combination with nivolumab in subjects with unresectable or metastatic melanoma.

Trial ID: NCT04695977

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Trial Details

We want to evaluate the safety and efficacy of the study drug, CMP-001, used in combination with an already approved drug, nivolumab, and determine if it can improve cancer treatment compared to nivolumab on its own.
Metastatic or unresectable melanoma is melanoma that has either spread to other parts of the body or is unable to be removed by surgery. The goals of treatment are to shrink or stop the growth of the disease where it has spread and stop it from spreading to new areas. Nivolumab is already approved to treat this type of cancer and will be provided intravenously. CMP-001 provides treatment directly into the tumor through an alternative mechanism than nivolumab, and the goal is to further increase the efficacy of treating the cancer through this dual approach.
This study is divided into two phases: Phase 2 and Phase 3. The Phase 2 part of the study is designed to look at the safety and objective response rate (ORR) following treatment. The Phase 3 part of the study is designed to look at additional safety measures along with the progression-free survival (PFS), overall survival (OS), and additional efficacy measures. To determine if you can take part in the study, you will need to visit a study center to undergo medical tests and assessments. The eligibility visit and screening period will be up to 1 month before the start of the study.

Estimated Enrollment

450

Phase

2/3

Commitment to Diversity & Inclusion

Checkmate is committed to ensuring the safety of all study participants and has taken steps to recruit patients from different backgrounds and populations.

We will use this research study to collect information to determine if the investigational drug could one day be made available to the public.

Eligibility Criteria

Participants must:

Main criteria below. Note: Any additional criteria will be confirmed at the study clinic

Be male or female and at least 18 years of age.
Have unresectable or metastatic, stage 3 or stage 4 melanoma.
Have at least one tumor that meets the criteria for direct injection of drug treatment, and one or more other tumors that will be evaluated during treatment.
Be willing to provide a tumor biopsy, previous or newly obtained.
Have adequate organ function.
Be willing to use contraception.
Be able to provide written informed consent.

Participants must not have:

Main criteria below. Note: Any additional criteria will be confirmed at the study clinic

Uveal, acral, or mucosal melanoma.
Received prior systemic treatment for melanoma in the unresectable or metastatic setting (except adjuvant therapy)
Received prior therapy with CMP-001.
Steroid treatment greater than 10 mg/day.
Be pregnant or breastfeeding.
A life expectancy of less than 3 months.
Known additional malignancy that has progressed or required active treatment within the past 3 years (exceptions allowed).
History of adverse events to certain treatments.
Any concurrent uncontrolled illness, including mental illness or substance abuse, or an active/suspected illness or infection.
Participated in another clinical study of an investigational anticancer treatment within 30 days.

What Will Happen in This Study

Following the screening assessment, the participant will be placed in 1 of 2 groups. One group will receive CMP-001 and nivolumab, and the other will receive nivolumab alone. CMP-001 is given intratumorally (into the tumor) once a week for 7 weeks, followed by treatment once every 3 weeks. Nivolumab will be given intravenously once every 3 weeks. Evaluations will occur during and after treatment, at least through 30 weeks and up to 2 years.

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Where to Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location

Status

Athens, GA, 30607, United States, University Cancer & Blood Center, LLC

Inactive

Seattle, Washington, 98109, United States, Seattle Cancer Care Alliance

Recruiting

Dallas, TX, 75246, United States, Texas Oncology - Sammons Cancer Center

Inactive

San Marcos, CA, 92069, United States, California Cancer Associates for Research & Excellence, Inc.

Recruiting

Philadelphia, Pennsylvania, 19107, United States, Thomas Jefferson University Hospital

Recruiting

Columbus, OH, 43210, United States, Ohio State University Wexner Medical Center

Inactive

Hartford, Connecticut, 06103, United States, Hartford Healthcare

Inactive

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Frequently Asked Questions (FAQs)

What phase is this clinical trial in?

This study is phase 2/3, so will be combining a phase 2 trial and a phase 3 trial together. This means that the study drug has shown some efficacy in a previous trial(s), and now the sponsors and U.S. Food and Drug Administration (FDA) have enough confidence in the combination treatment for it to be evaluated in a combined 2/3 study design and in a larger population.

Why is this study being done?

This study is evaluating combination therapy of a PD-1 inhibitor with a toll like receptor-9 (TLR9) agonist in melanoma. Despite the improved outcomes with PD-1 inhibitors in melanoma, more than 55% of patients do not respond to them, and half do not respond to combination therapy with a CTLA-4 inhibitor. Therefore, there remains a critical need for innovative anticancer therapy in this condition.

Will the drug combinations being evaluated in this study be safe?

The preliminary safety and efficacy data from an ongoing Phase 2 Investigator Sponsored Trial of the same drugs, CMP-001 in combination with nivolumab, in subjects with high-risk resectable melanoma (Study HCC 17-169) have demonstrated a tolerable safety profile to date.

How long is the study duration?

The assessment of the phase 2 portion of the study will be approximately 30 weeks after the last subject is enrolled. If phase 2 results are positive, and the phase 3 portion of the trial commences, then it could continue up through 2 years. Participants will be evaluated for safety and efficacy during and after treatment.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical clinical trial look like?

Clinical trials determine the safety and effectiveness of new treatments that are not yet approved by the U.S. Food and Drug Administration (FDA). A research plan or protocol is created that outlines how trial participants may receive interventions, which can include investigational medications, devices, or procedures. This trial compares a new medical approach to a standard treatment option already available. The study team will share more details before you participate.

Does this study use a placebo?

This study is an open label study, meaning study participants and researchers both know which treatment the patient is receiving. Open-label trials can be used to compare treatments or gather additional information about the long-term effects in the intended patient population.

Will I receive reimbursement for being in this study?

Any reimbursement for taking part of this study will be confirmed by the study clinic.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include: - Your name, address, telephone number, health insurance number where applicable. - Your age, gender, ethnic and racial background. - Lifestyle information; health and medical history. - Your study treatments and response to study treatments. - Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.