What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy with agents like carboplatin and paclitaxel, often cause side effects including nausea, vomiting, hair loss, neuropathy, and myelosuppression. Treatments similar to Nivolumab (a PD-1 inhibitor) can lead to immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. These side effects reflect the body's immune response being activated against normal tissues.

What prior FDA approvals exist?

The FDA has approved several immunotherapies and targeted therapies for the treatment of ovarian cancer. Pembrolizumab, a PD-1 inhibitor, has been approved for use in ovarian cancer with specific biomarkers such as microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). Additionally, bevacizumab, an anti-VEGF antibody, is approved in combination with chemotherapy for advanced ovarian cancer. While there are no specific FDA approvals for Anti-CEACAM1 antibodies in ovarian cancer, the ongoing research into CM-24 in combination with Nivolumab represents a promising area of study in immunotherapy for this disease.

What other types of research exist?

Promising novel alternatives for ovarian cancer treatment in 2024 include the combination of durvalumab (anti-PD-L1) and tremelimumab (anti-CTLA-4) with neoadjuvant chemotherapy. This combination is currently being studied for its potential to improve progression-free survival in advanced-stage ovarian cancer.

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Monoclonal Antibodies

CM24 + Nivolumab for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by Famewave Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously treated subjects with recurrent and/or metastatic NSCLC, pancreatic cancer, ovarian cancer, papillary thyroid cancer, colorectal adenocarcinoma, and melanoma with documented progression/intolerance following at least one previous therapy (and not more than 2 previous regimens)

Subjects with histologically confirmed advanced metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines

Must not have

Received more than two prior systemic regimens for the metastatic disease

History of weight loss >10% over the 2 months prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders that can affect cell counts and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has returned or spread, and I've had 1-2 treatments but they didn't work or caused side effects.

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My cancer is advanced pancreatic cancer, confirmed by tests.

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My cancer has worsened after 1 treatment for advanced disease.

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I have at least one tumor that can be measured and has grown since my last cancer treatment.

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I am fully active or can carry out light work.

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My brain cancer has not changed recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had more than two treatments for my cancer after it spread.

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I have lost more than 10% of my weight in the last 2 months.

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I have no severe side effects from previous cancer treatments.

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I am currently being treated for another cancer.

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I have brain metastases that haven't been treated.

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I had side effects from previous immunotherapy targeting PD-1/PD-L1.

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My immune system is very weak.

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I have not had major surgery in the last 4 weeks.

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I have not received a live vaccine in the last 30 days.

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I do not have serious health issues like heart disease, severe lung problems, or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Incidence of treatment emergent adverse events

Part C: Safety and tolerability

Part D: Overall survival

Secondary study objectives

Area under the serum concentration curve [AUC]

Drug clearance

Half life

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nivolumab, a PD-1 inhibitor, enhances the immune system's ability to target and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. CM-24, an anti-CEACAM1 antibody, targets the CEACAM1 protein to restore immune function and inhibit tumor growth. These treatments are significant for ovarian cancer patients as they leverage the body's immune system to combat cancer, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.