Study of REGN2810 in Adults With Cervical Cancer

Phase 1

• Conditions: recurrent or metastatic, cervical cancer; MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000350-19-IT
• Lead Sponsor: REGENERON PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 590

Inclusion Criteria

The criteria listed below are not intended to contain all considerations relevant to a patient’s potential participation in this clinical trial.
1. Recurrent, persistent, and/or metastatic cervical cancer, for which there is not a curativeintent option (surgery or radiation therapy with or without chemotherapy). Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.
2. Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer).
3. Patient must have measurable disease as defined by RECIST
4. Eastern Cooperative Oncology Group (ECOG) performance status =1
5. =18 years old
6. Adequate organ or bone marrow function
7. Received prior bevacizumab therapy or had clinically documented reason why not administered
8. Received prior paclitaxel therapy or had clinically documented reason why not administered
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 514
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
3. Prior treatment with immune modulating agents (other than anti-PD-1/PD-L1 agents) within 28 days (within 90 days if there was an immune-related adverse event).
4. Active or untreated brain metastases.
5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug REGN2810 [cemiplimab] or IC chemo) .
6. Active infection requiring systemic therapy.
7. History of pneumonitis within the last 5 years
8. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
9. History of malignancy other than cervical cancer within 3 years of first planned dose of REGN2810, except for tumors with negligible risk of metastasis.
10. Prior treatment with live vaccines within 30 days of initial administration of REGN2810. Patients must not be treated with live vaccines during the study and up to 5 half-lives following the last dose of study drug.
11.Patients with prior treatment on any clinical trial within 30 days of the initial administration of study drug(excepts Non-interventional and observational trials).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified