NCT02400385

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

March 16, 2015

Last Update Submit

January 30, 2017

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Objective response by RECIST 1.1

    3 years

Secondary Outcomes (3)

  • Grade 3, 4, or 5 adverse events in patients on trial

    3 years

  • Change in peripheral blood lymphocytes

    3 years

  • Progression-free survival by RECIST

    3 years

Study Arms (1)

Treatment

EXPERIMENTAL

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: sunitinibDrug: nivolumab

Interventions

sunitinibDRUG

sunitinib 50mg/day po, 4 weeks on 2 weeks off

Also known as: Sutent
Treatment
nivolumabDRUG

nivolumab 3mg/kg IV ever 2 weeks

Also known as: Opdivo
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unresectable stage 3 or stage 4 metastatic melanoma
  • 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.
  • 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. .
  • Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1.
  • 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
  • Karnofsky performance status \> 60 %.
  • Male or female, 18 years of age or older.
  • 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.
  • +1 more criteria

You may not qualify if:

  • Brain metastasis requiring daily corticosteroid dosage over 7 .5mg/ day prednisone or equivalent.
  • 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.
  • 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.
  • NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
  • 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.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade \> 2.
  • Prolonged QTc interval on baseline EKG (\>450 msec for males or \>470 msec for females)
  • Uncontrolled hypertension (\> 170/100 mm hg despite optimal medical therapy).
  • Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g., QOL, are allowed.
  • Concomitant treatment with a drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)
  • Use of potent CYP3A4 inhibitors and inducers 7 and 12 days before dosing, respectively (see below).
  • Definite history of ulcerative colitis or Crohn's disease or lupus
  • History of allogeneic transplant.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Pacific Medical Center Research Institute

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Minor DR, Kashani-Sabet M, Garrido M, O'Day SJ, Hamid O, Bastian BC. Sunitinib therapy for melanoma patients with KIT mutations. Clin Cancer Res. 2012 Mar 1;18(5):1457-63. doi: 10.1158/1078-0432.CCR-11-1987. Epub 2012 Jan 18.

    PMID: 22261812BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

SunitinibNivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • David R Minor, M.D.

    California Pacific Medical Center Research Institute

    STUDY CHAIR

  • Kevin B Kim, MD

    California Pacific Melanoma Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 27, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)