Study of REGN2810 in Adults With Cervical Cancer

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-18
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 436

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 within 6 months of last dose of platinum therapy that was used to treat metastatic, persistent or current 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 349
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 87

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)prior to enrollment date.
4. KActive or untreated brain metastases.
5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810.
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. Known allergy to doxycycline or other tetracycline antibiotics
10. History of malignancy other than cervical cancer within 3 years of first planned dose of REGN2810, except for tumors with negligible risk of metastasis

Study & Design

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