690 Participants Needed

REGN4018 + Cemiplimab for Ovarian Cancer

Recruiting at 78 trial locations
CT
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: Regeneron Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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, if you are on anti-hypertensive medication, you must be on a stable regimen.

What data supports the effectiveness of the drug REGN4018 + Cemiplimab for ovarian cancer?

The research indicates that ovarian cancer is often resistant to treatments, but there are ongoing efforts to improve response rates by combining different therapies, including immune checkpoint inhibitors like Cemiplimab. Although direct evidence for REGN4018 + Cemiplimab is not provided, similar strategies are being explored to enhance the effectiveness of immunotherapy in ovarian cancer.12345

What safety data exists for Cemiplimab (Libtayo) in humans?

Cemiplimab (Libtayo) has been approved for use in certain types of skin and lung cancers, with common side effects including fatigue, rash, and diarrhea. It works by helping the immune system attack cancer cells, but it can also cause the immune system to attack normal organs and tissues, which may lead to serious side effects.16789

How is the drug REGN4018 + Cemiplimab different from other ovarian cancer treatments?

REGN4018 + Cemiplimab is unique because it combines an immune checkpoint inhibitor (cemiplimab) with a bispecific antibody (REGN4018) that targets ovarian cancer cells, potentially enhancing the immune system's ability to fight the cancer. This approach is different from traditional chemotherapy, which directly targets cancer cells, and may offer a new option for patients with ovarian cancer.49101112

What is the purpose of this trial?

The main purpose of this study is to:* Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus* The study will also look at the levels of REGN4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). This is called pharmacokinetics* The study will also look at any signs that REGN4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus* To find out how safe and tolerable the sarilumab pretreatment is, in combination with REGN4018 and cemiplimab

Research Team

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for adults with recurrent ovarian, fallopian tube, or peritoneal cancer who've had platinum-based therapy or are intolerant to it. They should have no standard treatment options left and a life expectancy of at least 3 months. Those with specific heart conditions, recent anti-PD-1/PD-L1 therapy, MUC16-targeted therapy history, untreated brain tumors or CNS metastases aren't eligible.

Inclusion Criteria

My organs and bone marrow are working well.
I have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer.
I have no standard treatment options left.
See 5 more

Exclusion Criteria

I have a history of heart issues as described in the study details.
My high blood pressure is under control with stable medication.
I have been treated with a therapy targeting MUC16 before.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of REGN4018 alone or with cemiplimab to determine safety and optimal dosing

Up to 62 weeks

Dose Expansion

Participants receive the determined dose of REGN4018 alone or with cemiplimab to further evaluate safety and efficacy

Up to 62 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

  • Cemiplimab
  • REGN4018
Trial Overview The study tests REGN4018 alone and combined with cemiplimab in two phases: Dose Escalation to find the safest dose and Dose Expansion to evaluate effectiveness by tumor response rates. It also examines side effects profiles, drug levels in the body (pharmacokinetics), and impacts on quality of life.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment2 Interventions
REGN4018 administration
Group II: Combination TherapyExperimental Treatment2 Interventions
REGN4018 and cemiplimab administration

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺
Approved in European Union as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Basal cell carcinoma (BCC)
  • Non-small cell lung cancer (NSCLC)
🇨🇦
Approved in Canada as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇧🇷
Approved in Brazil as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

In the phase III IMagyn050 trial involving patients with newly diagnosed ovarian cancer, the addition of atezolizumab to standard chemotherapy did not improve progression-free survival (PFS) in patients with BRCA1/2 mutations or homologous recombination deficiency (HRD).
Despite the presence of BRCA1/2 mutations or HRD, most ovarian tumors exhibited low tumor mutation burden (TMB), indicating that genomic instability does not predict enhanced sensitivity to immune checkpoint inhibitors like atezolizumab.
Influence of Genomic Landscape on Cancer Immunotherapy for Newly Diagnosed Ovarian Cancer: Biomarker Analyses from the IMagyn050 Randomized Clinical Trial.Landen, CN., Molinero, L., Hamidi, H., et al.[2023]
In a study involving 145 patients with advanced ovarian cancer, oregovomab did not significantly improve the time to relapse (TTR) compared to placebo, with median TTRs of 13.3 months for oregovomab and 10.3 months for placebo.
However, in a specific subgroup of patients with favorable prognostic indicators (the successful front-line therapy population), oregovomab showed a promising increase in TTR to 24.0 months compared to 10.8 months for placebo, suggesting potential benefits for this subgroup that warrant further investigation.
Randomized, placebo-controlled study of oregovomab for consolidation of clinical remission in patients with advanced ovarian cancer.Berek, JS., Taylor, PT., Gordon, A., et al.[2019]
In a phase 1b/2 clinical trial involving 118 patients with recurrent platinum-sensitive epithelial ovarian cancer, the combination of ralimetinib with gemcitabine and carboplatin showed a statistically significant improvement in progression-free survival (PFS), with a median of 10.3 months compared to 7.9 months for the placebo group.
The safety profile of the ralimetinib combination therapy was generally consistent with standard chemotherapy, although there was a higher incidence of grade 3/4 elevated alanine aminotransferase in the ralimetinib group.
A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer.Vergote, I., Heitz, F., Buderath, P., et al.[2022]

References

Influence of Genomic Landscape on Cancer Immunotherapy for Newly Diagnosed Ovarian Cancer: Biomarker Analyses from the IMagyn050 Randomized Clinical Trial. [2023]
Randomized, placebo-controlled study of oregovomab for consolidation of clinical remission in patients with advanced ovarian cancer. [2019]
A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer. [2022]
A phase II study of GM-CSF and rIFN-gamma1b plus carboplatin for the treatment of recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer. [2021]
Challenges for immunotherapy for the treatment of platinum resistant ovarian cancer. [2022]
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]
Cemiplimab: First Global Approval. [2023]
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]
Regorafenib or Tamoxifen for platinum-sensitive recurrent ovarian cancer with rising CA125 and no evidence of clinical or RECIST progression: A GINECO randomized phase II trial (REGOVAR). [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Ruxolitinib synergistically enhances the anti-tumor activity of paclitaxel in human ovarian cancer. [2021]
Intratumoral expression analysis reveals that OX40 and TIM-3 are prominently expressed and have variable associations with clinical outcomes in high grade serous ovarian cancer. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Recombinant CD40 ligand therapy has significant antitumor effects on CD40-positive ovarian tumor xenografts grown in SCID mice and demonstrates an augmented effect with cisplatin. [2013]
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