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A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

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. Identifier: NCT02400385
Recruitment Status : Withdrawn (With recent advances in immunotherapy scientific question not significant)
First Posted : March 27, 2015
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
California Pacific Medical Center Research Institute

Brief Summary:
This will be a phase II trial of the combination of sunitinib and nivolumab in patients with advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.

Condition or disease Intervention/treatment Phase
Melanoma Drug: sunitinib Drug: nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Treatment
Sunitinib 50mg/day, 4 weeks on and 2 weeks off, and concurrent nivolumab 3mg/kg iv every 2 weeks, both for three years if tolerated.
Drug: sunitinib
sunitinib 50mg/day po, 4 weeks on 2 weeks off
Other Name: Sutent

Drug: nivolumab
nivolumab 3mg/kg IV ever 2 weeks
Other Name: Opdivo

Primary Outcome Measures :
  1. Objective response by RECIST 1.1 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Grade 3, 4, or 5 adverse events in patients on trial [ Time Frame: 3 years ]
    Adverse events will be measured and recorded using CTAE criteria.

  2. Change in peripheral blood lymphocytes [ Time Frame: 3 years ]
    Change in total and lymphocyte subsets in select patients

  3. Progression-free survival by RECIST [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  1. Unresectable stage 3 or stage 4 metastatic melanoma
  2. A mutation, translocation, or fusion in the KIT gene in the patient's tumor felt to be potentially sensitive to tyrosine kinase inhibition. Expression of CD113 or other immunohistochemical test will not by itself satisfy this requirement.
  3. Evidence of measurable disease by RECIST criteria 1.2 Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable. .
  4. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1.
  5. Adequate organ function as defined by the following criteria:

    • Absolute neutrophil count (ANC) ≥1,000/µL
    • Platelets ≥75,000/µL
    • Hemoglobin ≥8.0 g/dL
    • Serum calcium ≤12.0 mg/dL
    • Serum creatinine ≤1.5 x ULN
    • Total serum bilirubin ≤1.5 x ULN
    • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy
  6. Karnofsky performance status > 60 %.
  7. Male or female, 18 years of age or older.
  8. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to undergoing study screening procedures.
  9. Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Brain metastasis requiring daily corticosteroid dosage over 7 .5mg/ day prednisone or equivalent.
  2. Prior therapy with sunitinib or anti-PD-1 or anti-PDL-1 antibodies (pembrolizumab, nivolumab, etc.) Prior therapy with other KIT inhibitors (dasatinib, nilotinib, imatinib, etc.) allowed but results from these patients will be analyzed separately.
  3. Major surgery or radiation therapy within 2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
  4. NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
  5. Any of the following within the 4 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic heart failure, or cerebrovascular accident.
  6. Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
  7. Prolonged QTc interval on baseline EKG (>450 msec for males or >470 msec for females)
  8. Uncontrolled hypertension (> 170/100 mm hg despite optimal medical therapy).
  9. Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g., QOL, are allowed.
  10. Concomitant treatment with a drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)
  11. Use of potent CYP3A4 inhibitors and inducers 7 and 12 days before dosing, respectively (see below).
  12. Definite history of ulcerative colitis or Crohn's disease or lupus
  13. History of allogeneic transplant.
  14. Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.

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 identifier (NCT number): NCT02400385

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United States, California
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
Sponsors and Collaborators
California Pacific Medical Center Research Institute
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Study Chair: David R Minor, M.D. California Pacific Medical Center Research Institute
Principal Investigator: Kevin B Kim, MD California Pacific Melanoma Center
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Responsible Party: California Pacific Medical Center Research Institute Identifier: NCT02400385    
Other Study ID Numbers: 703131-1
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors