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Study of REGN2810 in Adults With Cervical Cancer

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ClinicalTrials.gov Identifier: NCT03257267
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic platinum-refractory cervical cancer treated with either REGN2810 or investigator's choice (IC) chemotherapy.

The secondary objectives are:

  • To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy
  • To compare overall response rate (ORR) (partial response [PR] + complete response [CR]) of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1
  • To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy
  • To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE)
  • To compare quality of life (QOL) for patients treated with REGN2810 versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic, Platinum-refractory Cervical Cancer Drug: REGN2810 Drug: Investigator Choice (IC) Chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The treatment period begins with randomization to 1 of the treatment arms. Cycle length is 6 weeks; Planned treatment is for up to 96 weeks. The treatment phase ends when the patient discontinues study therapy. After completion of the treatment period, patients enter the follow up period, which continues until death or study completion, per the sponsor and the Gynecologic Oncology Group (GOG). Study closeout procedures will be implemented after the 330th OS event has been reported.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Therapy of Investigator's Choice Chemotherapy in Recurrent or Metastatic Platinum-Refractory Cervical Carcinoma
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : January 20, 2022
Estimated Study Completion Date : June 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Experimental Therapy
REGN2810
Drug: REGN2810
Intravenous (IV) administration every 3 weeks (Q3W)
Other Name: cemiplimab

Active Comparator: Control Therapy
Investigator choice (IC) chemotherapy
Drug: Investigator Choice (IC) Chemotherapy

IC chemotherapy options include:

  1. Antifolate: Pemetrexed
  2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan
  3. Nucleoside analogue: Gemcitabine
  4. Vinca alkaloid: Vinorelbine

The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.





Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Time from randomization up to approximately 32 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Time from randomization to the date of the first documented tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, up to approximately 32 months ]
  2. Overall Response Rate (ORR) [ Time Frame: Time from randomization to the date of the first documented tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, up to approximately 32 months ]
  3. Duration of response (DOR) [ Time Frame: Time between the date of first response (complete response or partial response) to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, up to approximately 32 months ]
  4. Quality of life (QOL) [ Time Frame: Time from randomization up to 100 weeks ]
    Quality of life will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] [ Time Frame: Time from randomization up to approximately 32 months ]
    TEAEs include adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities.(SAEs), deaths, and laboratory abnormalities.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

The criteria listed below are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

Key Inclusion Criteria:

  1. Recurrent, persistent, and/or metastatic cervical cancer, for which there is not a curative intent 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 recurrent cervical cancer
  3. Patient must have measurable disease as defined by RECIST 1.1.
  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

Key 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 systemic immune modulating agents (other than anti-PD-1/PD-L1 agents) that was within 28 days prior to enrollment, or within 90 days prior to enrollment if there was an immune related adverse event, or associated with toxicity that resulted in discontinuation of the immune modulating agent
  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 therapy
  7. History of pneumonitis within the last 5 years
  8. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
  9. Concurrent malignancy other than cervical cancer and/or history of malignancy other than cervical cancer within 3 years of first planned dose of study drug (REGN2810 [cemiplimab] or IC chemo, except for tumors with negligible risk of metastasis or death. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.

Note: Other protocol defined Inclusion/Exclusion may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257267


Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

  Show 48 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03257267     History of Changes
Other Study ID Numbers: R2810-ONC-1676
2017-000350-19 ( EudraCT Number )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female