Study of REGN2810 in Adults With Cervical Cancer

Phase 1

• Conditions: recurrent or metastatic cervical cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000350-19-GR
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 534

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 with squamous cell histology, for which there is not a curativeintent option (surgery or radiation therapy with or without chemotherapy).
a. Patients with acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma (AC)) will be enrolled from the original protocol through protocol Amendment 4. For the purpose of this study, AC will be stratified as adenocarcinoma.
b. Starting with protocol Amendment 5, only patients with squamous cell histology are eligible to enroll.

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 427
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

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 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 cemiplimab, except for tumors with negligible risk of metastasis.
10. Prior treatment with live vaccines within 30 days of initial administration of cemiplimab. 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