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Closed (no longer recruiting)Last updated: 7 February 2024

PIVOT-12: This Phase III study is trying to understand how effective combining a new immunotherapy drug (Bempegaldesleukin) with an existing immunotherapy drug (Nivolumab) is in people with who have had a melanoma removed and are at high risk of it coming backA 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)

Clinical summary

Summary

This is a randomised trial with experimental and active comparator arms. Participants in Experimental Arm 1 will receive 0.006mg/kg bempegaldesleukin (NKTR-214), administered intravenously in combination with 360mg nivolumab, every 3 weeks. Participants in the Active Comparator arm will receive 480mg nivolumab alone, administered intravenously every 4 weeks.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People12+

Phase

III

Trial Acronym

PIVOT-12

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Nektar Therapeutics

Scientific 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)

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.

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.
Message

Clinical trials have complex eligibility criteria.

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