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A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03122522
First received: April 18, 2017
Last updated: August 14, 2017
Last verified: August 2017
  Purpose
This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is sufficient for patients with early benefit compared to the usual way of trying to give 4 doses. If patients do not show early benefit after 2 doses, patients will be able to continue with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best interest of the patient.

Condition Intervention Phase
Metastatic Melanoma Drug: ipilimumab Drug: nivolumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • objective response rate [ Time Frame: at 6 weeks ]
    RECIST 1.1.


Estimated Enrollment: 60
Actual Study Start Date: April 17, 2017
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ipilimumab and nivolumab
Pts will receive 2 doses of ipilimumab 3mg/kg + nivolumab 1mg/kg every 3 weeks. Week 6, if pts have achieved a favorable antitumor effect by RECIST will begin maintenance nivolumab alone at 480mg every 4 weeks for 2 doses (week 6 & week 10) & repeat response assessments at week 12. If pts don't achieve a favorable antitumor effect at week 6, pt will get 2 additional doses of ipilimumab + nivolumab every 3 weeks & then will be assessed for response at week 12. If pts haven't achieved a favorable antitumor effect by week 12, if felt in the best interest for the pt as determined by the PI, pts may continue getting additional doses of ipilimumab + nivolumab with response reassessments after every 2 doses. Maintenance nivolumab will continued until unacceptable toxicity or confirmed disease progression. If pts have had an initial clinical benefit from therapy & subsequently experience progressive disease at any time, reinduction with combination ipilimuma+ nivolumab will be allowed.
Drug: ipilimumab
ipilimumab 3mg/kg
Drug: nivolumab
nivolumab 1mg/kg

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of unresectable III or stage IV metastatic melanoma.
  • Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).
  • No prior CTLA-4 or PD-1/PD-L1 therapy for the treatment of metastatic disease.
  • ECOG performance status of 0-1.
  • Life expectancy ≥ 4 months.
  • Screening laboratory parameters:

    • White blood cell (WBC) count ≥ 2000/μL;
    • Absolute neutrophil count (ANC) ≥ 1500/μL;
    • Platelets ≥ 100,000/μL;
    • Hemoglobin (Hgb) ≥ 9 g/dL;
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);
    • Total bilirubin ≤ 1.5 × ULN (< 3 mg/dL for subjects with Gilbert's disease);
    • Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dL] Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dL]
  • Age ≥ 18 years.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.

[Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).] Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 31 weeks after receipt of the final dose of investigational product.

Acceptable methods of effective contraception are described in the following table:

  • Barrier Methods - Male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide.
  • Intrauterine Device Methods-Copper T, or Levonorgestrel-releasing intrauterine system (e.g., Mirena®), also considered a hormonal method.
  • Hormonal Methods-Implants, hormone shot or injection, combined pill, minipilimumabll, or Patch.

Exclusion Criteria:

  • Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
  • Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
  • Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C infection. Antibody to Hepatitis B or C without evidence of active infection may be allowed.
  • History of severe allergic reactions to any unknown allergens or any components of the study drugs.
  • Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival.
  • Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of the first dose of study drug(s).
  • Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03122522

Contacts
Contact: Michael Postow, MD 646-888-4589 postowm@mskcc.org
Contact: Jedd Wolchok, MD, PhD 646-888-2315

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Postow, MD    646-888-4589      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Postow, MD    646-888-4589      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Michael Postow, MD    646-888-4589      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Michael Postow, MD    646-888-4589      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Postow, MD    646-888-4589      
Contact: Jedd Wolchok, MD, PhD    646-888-2315      
Principal Investigator: Michael Postow, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Michael Postow, MD    646-888-4589      
United States, Pennsylvania
Lehigh Valley Health Network Not yet recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, MD    610-402-7880      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Michael Postow, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03122522     History of Changes
Other Study ID Numbers: 17-162
Study First Received: April 18, 2017
Last Updated: August 14, 2017
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
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Memorial Sloan Kettering Cancer Center:
unresectable
III or stage IV
Ipilimumab
Nivolumab
17-162

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017