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Study of Cemiplimab in Adults With Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03257267
Recruitment Status : Active, not recruiting
First Posted : August 22, 2017
Last Update Posted : July 15, 2020
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 cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy.

The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are:

  • To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy
  • To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy
  • To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE)
  • To compare quality of life (QOL) for patients treated with cemiplimab 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
Squamous Cell Carcinoma (SCC) Recurrent or Metastatic, Platinum-refractory Cervical Cancer Drug: Cemiplimab Drug: Investigator Choice (IC) Chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 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 340th OS event has been reported in patients with squamous cell carcinoma.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Experimental Therapy
Cemiplimab
Drug: Cemiplimab
Intravenous (IV) administration every 3 weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo

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 44 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Will be analyzed at time of primary outcome measure; approximately 44 months ]
  2. Objective Response Rate (ORR) [ Time Frame: Will be analyzed at time of primary outcome measure; approximately 44 months ]
  3. Duration of response (DOR) [ Time Frame: Will be analyzed at time of primary outcome measure; approximately 44 months ]
  4. Quality of life (QOL) [ Time Frame: Will be analyzed at time of primary outcome measure; approximately 44 months ]
    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: Will be analyzed at time of primary outcome measure; approximately 44 months ]
    TEAEs include adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities.



Information from the National Library of Medicine

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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 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
  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 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 other systemic immune-modulating agents that was

    1. within fewer than 4 weeks (28 days) of the enrollment date, or
    2. associated with irAEs of any grade within 90 days prior to enrollment, or
    3. 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 cemiplimab or IC chemo)
  6. Active infection requiring therapy
  7. History of pneumonitis within the last 5 years
  8. History of documented allergic reactions 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 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


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


Locations
Show Show 105 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03257267    
Other Study ID Numbers: R2810-ONC-1676
2017-000350-19 ( EudraCT Number )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Cemiplimab
Carcinoma
Uterine Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents