Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT03071406 |
Recruitment Status :
Active, not recruiting
First Posted : March 6, 2017
Results First Posted : May 19, 2023
Last Update Posted : February 20, 2024
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Condition or disease | Intervention/treatment | Phase |
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Merkel Cell Carcinoma Skin Cancer | Drug: Nivolumab Drug: Ipilimumab Radiation: Stereotactic Body Radiation Therapy (SBRT) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants are randomly assigned in a 1:1 ratio to Arm A (nivolumab + ipilimumab), or Arm B (nivolumab + ipilimumab + SBRT). |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma |
Actual Study Start Date : | March 14, 2017 |
Actual Primary Completion Date : | April 6, 2022 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm A: Nivolumab + Ipilimumab
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity.
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Drug: Nivolumab
Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Other Name: OPDIVO Drug: Ipilimumab Ipilimumab 1 mg/kg/dose IV q6 weeks.
Other Name: YERVOY |
Active Comparator: Arm B: Nivolumab + Ipilimumab + SBRT
Nivolumab every 2 weeks and Ipilimumab every 6 weeks until progression or unacceptable toxicity. Stereotactic Body Radiation Therapy (SBRT) to be given at the start of week 2.
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Drug: Nivolumab
Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
Other Name: OPDIVO Drug: Ipilimumab Ipilimumab 1 mg/kg/dose IV q6 weeks.
Other Name: YERVOY Radiation: Stereotactic Body Radiation Therapy (SBRT) Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
Other Name: SBRT |
- Best Overall Response [ Time Frame: Up to 18 months ]Overall response according to Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) including Complete Response (CR) + Partial Response (PR).
- Progression Free Survival (PFS) [ Time Frame: up to 28 months ]Median Progression Free Survival with 95% Confidence Interval. Progression is defined as progressive tumor lesions per immune-related Response Evaluation in Solid Tumors (irRECIST) definition, or appearance of one or more new Merkel cell carcinoma lesions, which can be local or distant in location from the irradiated lesions.
- Overall Survival (OS) [ Time Frame: Up to 30 months ]Median Overall Survival with 95% Confidence Interval. The length of time from the start of treatment until death from any cause.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2
- Active disease measurable by CT, MRI or clinical exam.
- Prior chemotherapy or immunotherapy will be allowed if new or persistent measurable site(s) of disease are present.
- Prior radiation therapy will be allowed if there is active measurable disease burden.
- Must be either recurrent, unresectable or Stage IV American Joint Committee on Cancer (AJCC) (7th edition) and have histologically confirmed Merkel cell carcinoma with at least 2 distinct lesions in order to be eligible.
- Must have at least 2 distinct lesions as documented by a complete physical examination or imaging studies within 4 weeks prior to randomization. Imaging studies must include a diagnostic CT scan of the involved disease sites and all known sites of resected disease and brain magnetic resonance (MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no known history of resected brain lesions).
- Tumor tissue from the core biopsy or resected site of disease must be provided for biomarker analyses.
Exclusion Criteria:
- History of Grade 3 toxicity or use of infliximab with prior immunotherapy
- Patients with active brain metastasis.
- Active, known, or suspected autoimmune disease. Potential participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
- Patients with prior history of non-Merkel cell carcinoma malignancies are excluded except adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia or other indolent diseases not requiring therapy; adequately treated, with curative intent, cancer from which the patient is currently in complete remission per investigator's judgment; or patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible.
- A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
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): NCT03071406
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Ohio | |
Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Evan Wuthrick, M.D | H. Lee Moffitt Cancer Center and Research Institute |
Documents provided by H. Lee Moffitt Cancer Center and Research Institute:
Publications:
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT03071406 |
Other Study ID Numbers: |
MCC-18786 CA209-737 ( Other Identifier: Bristol-Myers Squibb ) |
First Posted: | March 6, 2017 Key Record Dates |
Results First Posted: | May 19, 2023 |
Last Update Posted: | February 20, 2024 |
Last Verified: | February 2024 |
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.: | No |
Merkel cell carcinoma (MCC) Metastatic Metastasis Stereotactic body radiation therapy (SBRT) Immunology |
Antibody Nivolumab Ipilimumab Metastatic skin cancer Cutaneous |
Carcinoma, Merkel Cell Carcinoma Skin Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Skin Diseases Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections |
Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |