CM24 + Nivolumab for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment combination for individuals with advanced solid tumors, including metastatic pancreatic cancer. It evaluates the safety and tolerability of CM-24 (an experimental treatment) and nivolumab (an immunotherapy drug), with some participants also receiving additional chemotherapy drugs. This trial may suit those who have tried other cancer treatments without success and have pancreatic cancer that has progressed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain treatments recently, like live vaccines within 30 days or radiation within two weeks before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of CM24 and nivolumab is generally safe for people. In earlier studies, only six serious side effects, unrelated to CM24 or nivolumab, were reported, including diarrhea and low potassium levels. When combined with other drugs like nab-paclitaxel and gemcitabine, some side effects appeared, but they were not linked to CM24 or nivolumab. Similarly, when used with Nal-IRI, 5-FU, and LV, there were consistent improvements in various areas, and the treatment was well-tolerated. Overall, treatments involving CM24 and nivolumab have demonstrated a strong safety record in trials so far.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of CM24 and Nivolumab for solid tumors because it offers a fresh approach by combining an innovative checkpoint inhibitor with an existing immunotherapy. CM24 is unique as it targets CEACAM1, a molecule involved in tumor immune evasion, potentially enhancing the immune system's ability to fight cancer. When paired with Nivolumab, which blocks the PD-1 pathway, this duo aims to provide a more potent anti-tumor response than current treatments that typically focus on single pathways. Additionally, the study explores various combinations with established chemotherapy agents, seeking to optimize the therapeutic impact in ways traditional treatments for solid tumors might not achieve.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors and metastatic pancreatic cancer?
Research has shown that combining CM24 and nivolumab may help treat advanced solid tumors. In this trial, some participants will receive this combination. Earlier studies demonstrated that people lived longer with this combination, surviving an average of 8.7 months compared to 3.6 months with chemotherapy alone. For those with metastatic pancreatic cancer, other participants in this trial will receive CM24 and nivolumab alongside chemotherapy drugs like nab-paclitaxel and gemcitabine, which improved results even further. This combination also extended the time before the disease worsened, compared to chemotherapy alone. These findings suggest that these treatments could help people live longer and slow disease progression.14678
Who Is on the Research Team?
Michael Schickler, PhD
Principal Investigator
Famewave Ltd.
Are You a Good Fit for This Trial?
Adults with certain advanced solid tumors or metastatic pancreatic cancer, who have tried at least one but no more than two previous therapies. They must have a measurable tumor, stable brain metastases if present, and be in good physical condition (ECOG score of 0 or 1). Women able to bear children and men must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CM24 in combination with nivolumab, with additional chemotherapy agents in certain parts of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- CM-24
- Gemcitabine
- Nab paclitaxel
- Nal-IRI
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Famewave Ltd.
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania