Trial record 1 of 1 for:
20-214-29
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
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| ClinicalTrials.gov Identifier: NCT04410445 |
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Recruitment Status :
Terminated
((Sponsor decision))
First Posted : June 1, 2020
Last Update Posted : November 18, 2022
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Sponsor:
Nektar Therapeutics
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nektar Therapeutics
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Brief Summary:
The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma Melanoma Stage III Melanoma Stage IV Melanoma (Skin) | Biological: Bempegaldesleukin Biological: Nivolumab | Phase 3 |
The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN] metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC] 8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for recurrence.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 775 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients will be randomized in a 1:1 ratio to one of two treatment arms |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12) |
| Actual Study Start Date : | July 27, 2020 |
| Actual Primary Completion Date : | September 19, 2022 |
| Actual Study Completion Date : | September 19, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
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Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
Biological: Nivolumab Specified dose on specified days
Other Names:
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Active Comparator: Nivolumab
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
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Biological: Nivolumab
Specified dose on specified days
Other Names:
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Primary Outcome Measures :
- RFS of bempegaldesleukin plus nivolumab versus nivolumab alone by BICR, is defined as the time between date of randomization and date of first recurrence, new primary melanoma, or all-cause death [ Time Frame: Approximately up to 60 months ]
Secondary Outcome Measures :
- Overall Survival (OS) defined as the time between the date of randomization and the date of death due to any cause [ Time Frame: Approximately up to 83 months ]
- Distant metastasis-free survival (DMFS) by BICR and by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry. [ Time Frame: Approximately up to 60 months ]To evaluate distant metastasis-free survival (DMFS) by BICR and by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry. Distant Metastasis Free Survival is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause.
- Overall safety and tolerability of bempegaldesleukin plus nivolumab will be measured by the incidence of AEs, SAEs, deaths, and laboratory abnormalities using CTCAE Version 5.0 criteria [ Time Frame: Approximately up to 60 months ]
- Patient Reported Outcomes will be measured by changes from baseline in scores for the global health/quality of life and physical functioning subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire [ Time Frame: Approximately up to 60 months ]
- The predictive strength of PD-L1 expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level [ Time Frame: Approximately up to 60 months ]
- RFS by Investigator will be measured similarly to the primary endpoint, but recurrence and new primary melanoma will be decided by the Investigator [ Time Frame: Approximately up to 60 months ]
- Time to disease progression after the next line of treatment for study patients following discontinuation of bempegaldesleukin plus nivolumab versus nivolumab [ Time Frame: Approximately up to 60 months ]To evaluate time to disease progression after the next line of treatment for study patients following discontinuation of bempegaldesleukin plus nivolumab versus nivolumab
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients, age 12 years or older at the time of signing the informed consent form (age 18 years or older where local regulations, countries, and/or institutional policies do not allow for patients < 18 years of age (adolescents) to participate). In regions where adolescents are not allowed to participate in the study due to age restrictions, enrolled patients must be ≥ 18 years of age.
- Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.
- Tumor tissue available from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for stratification purposes.
- Disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.
Exclusion Criteria:
- History of ocular/uveal melanoma or mucosal melanoma.
- Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
- Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2 (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways).
- Prior malignancy active within the previous 3 years except for locally potentially curable cancers that have been apparently cured.
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): NCT04410445
Locations
Show 212 study locations
Sponsors and Collaborators
Nektar Therapeutics
Bristol-Myers Squibb
Investigators
| Study Director: | Study Director | Nektar Therapeutics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nektar Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04410445 |
| Other Study ID Numbers: |
20-214-29/CA045-022 |
| First Posted: | June 1, 2020 Key Record Dates |
| Last Update Posted: | November 18, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Nektar Therapeutics:
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CD122-Biased Agonist CD122-Biased Cytokine IL-2 Receptor Agonist NKTR-214 Bempegaldesleukin IL-2 Immunotherapy BEMPEG Nivolumab |
Opdivo® NIVO Adjuvant Skin Cancer Resectable Melanoma High Risk of Recurrence Melanoma Post Resection Checkpoint Inhibitor |
Additional relevant MeSH terms:
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Melanoma Recurrence Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Disease Attributes Pathologic Processes Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |