Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Trial acronym
R2810-ONC-1676
Clinical summary
Summary
Eligible patients will be randomised to receive Cemiplimab or the investigator's choice of chemotherapy for up to 96 weeks. The different chemotherapy options for the investigator to choose from include: (1) Antifolate: Pemetrexed, (2) Topoisomerase 1 inhibitor: Topotecan or Irinotecan, (3) Nucleoside analogue: Gemcitabine or (4) Vinca alkaloid: Vinorelbine. Following the treatment phase, patients will enter the follow up period, which will continue until death, completion of the study or withdrawal of the patient.
Conditions
This trial is treating people with cervical cancer
Eligibility
Inclusion
The criteria listed below are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.
-
Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy).
- Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) as defined in the protocol
- Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer)
- Patient must have measurable disease as defined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- ≥18 years old
- Adequate organ or bone marrow function
- Received prior bevacizumab therapy or had clinically documented reason why not administered
- Received prior paclitaxel therapy or had clinically documented reason why not administered
Exclusion
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
-
Prior treatment with other systemic immune-modulating agents that was
- within fewer than 4 weeks (28 days) of the enrollment date, or
- associated with irAEs of any grade within 90 days prior to enrollment, or
- associated with toxicity that resulted in discontinuation of the immune modulating agent
- Active or untreated brain metastases
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo)
- Active infection requiring therapy
- History of pneumonitis within the last 5 years
- History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
- Concurrent malignancy other than cervical cancer and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or death, such as adequately treated cutaneous squamous cell carcinoma or basal cell carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.
Note: Other protocol defined Inclusion/Exclusion apply
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Regeneron Pharmaceuticals
Scientific Title
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information