79 Participants Needed

CM24 + Nivolumab for Solid Tumors

Recruiting at 19 trial locations
NY
MS
YZ
HN
Overseen ByHadas Nachmanson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of new and existing drugs to treat patients with severe forms of cancer. The treatment aims to boost the immune system's ability to fight cancer and directly kill cancer cells.

Who Is on the Research Team?

MS

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

I have had a recent biopsy after my last cancer treatment.
I have at least one tumor that can be measured and has grown since my last cancer treatment.
My cancer is advanced pancreatic cancer, confirmed by tests.
See 7 more

Exclusion Criteria

I had side effects from previous immunotherapy targeting PD-1/PD-L1.
My immune system is very weak.
I have had more than two treatments for my cancer after it spread.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CM24 in combination with nivolumab, with additional chemotherapy agents in certain parts of the study

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • CM-24
  • Gemcitabine
  • Nab paclitaxel
  • Nal-IRI
  • Nivolumab
Trial Overview The trial is testing the safety and effectiveness of CM-24 combined with nivolumab, sometimes along with other chemotherapy drugs like Nab paclitaxel/Gemcitabine or Nal-IRI/5-FU/LV. It's an open-label study where everyone knows what treatment they're getting.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Active Control
Group I: Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineExperimental Treatment1 Intervention
Group II: Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVExperimental Treatment1 Intervention
Group III: Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineExperimental Treatment1 Intervention
Group IV: Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVExperimental Treatment1 Intervention
Group V: Part A- Dose escalation of CM24 in combination with nivolumabExperimental Treatment1 Intervention
Group VI: Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LVActive Control1 Intervention
Group VII: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Famewave Ltd.

Lead Sponsor

Trials
2
Recruited
110+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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