Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01585194
First received: April 23, 2012
Last updated: June 4, 2015
Last verified: June 2015
  Purpose

The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma.

Ipilimumab is designed to increase the immune system's ability to fight cancer.

Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body's immune system to work against tumor cells.


Condition Intervention Phase
Melanoma
Uveal Melanoma
Drug: Nivolumab
Drug: Ipilimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Response defined as those patients who achieve RECIST complete response plus partial response (CR + PR). Overall response applied for interpreting the criteria of the Simon two-stage design.


Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Kaplan-Meier method used to assess the distribution of time-to-event variables, including overall survival, progression-free survival, and landmark analysis where possible.


Estimated Enrollment: 52
Study Start Date: November 2012
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab + Ipilimumab

Induction Phase:

During the induction phase, patients treated with Nivolumab 1mg/kg plus Ipilimumab 3 mg/kg (+/- 7 days) for a total of four doses (week 1, 4, 7, 10). The induction phase continues through week 12.

Maintenance Phase:

For patients who have not experienced disease progression or unmanageable toxicity by week 12, a maintenance phase will begin. Maintenance treatment consists of Nivolumab monotherapy 3 mg/kg every 2 weeks until disease progression or unmanageable toxicity as deemed by the clinical investigator.

Drug: Nivolumab

Induction Phase:

1mg/kg by vein for a total of four doses (week 1, 4, 7, 10). The induction phase continues through week 12.

Other Names:
  • BMS-936558
  • Opdivo
Drug: Ipilimumab

Induction Phase:

3 mg/kg by vein for a total of four doses (week 1, 4, 7, 10). The induction phase continues through week 12.

Maintenance Phase:

For patients who have not experienced disease progression or unmanageable toxicity by week 12:

Nivolumab 3 mg/kg by vein every 2 weeks until disease progression or unmanageable toxicity as deemed by the clinical investigator.

Other Names:
  • Yervoy
  • BMS-734016
  • MDX010

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to give written informed consent.
  2. History of uveal melanoma and documented metastatic disease with at least one measurable lesion is required. which is >/= 1 cm x 1 cm (on spiral CT or equivalent).
  3. Any number of prior therapies is allowed.
  4. Required values for initial laboratory tests: WBC >/= 2000/uL, ANC >/= 1500/uL, Platelets >/= 100 x 10^3/uL, Hemoglobin >/= 9 g/dL, Creatinine </= 1.5 x ULN or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula): 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, AST/ALT</= 3 x ULN for patients without liver metastasis,</= 5 x ULN for liver metastases, Bilirubin </= 1.5 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
  5. In suspected patients no active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
  6. Performance status ECOG 0-1.
  7. Men and women, >/= 18 years of age. Because no dosing or adverse event data are currently available on the use of ipilimumab in patients </= 18 years of age, minors are excluded from this study.
  8. Baseline imaging in the form of CT chest, abdomen, pelvis with oral and intravenous contrast within 28 days of study entry. For patients with a contrast allergy, choice of alternative body imaging will be at the discretion of the investigator or his designee. MRI of the brain is only needed if clinically indicated.
  9. Prior to start of treatment must be more than 21 days elapsed from surgery, radiation therapy, or prior chemotherapy. More than 42 days elapsed from prior immune therapy including vaccines.
  10. Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  1. Untreated primary uveal melanoma except in cases where metastatic disease is diagnosed at the time of primary disease.
  2. Metastatic uveal melanoma patients with bone-only disease.
  3. Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, breast, or prostate.
  4. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment,
  5. Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
  6. Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
  7. A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist.
  8. Concomitant therapy with any of the following: tamoxifen, toremifene, IL 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids greater than physiologic replacement doses. Ocular steroid use is acceptable.
  9. Women of childbearing potential (WOCBP)who: (a.) are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for up to 26 weeks after cessation of study drug, or (b.) have a positive pregnancy test at baseline, or (c.) are pregnant or breastfeeding.
  10. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
  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: NCT01585194

Contacts
Contact: Sapna P. Patel, MD 713-792-2921

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Sapna P. Patel, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01585194     History of Changes
Other Study ID Numbers: 2011-0919, NCI-2012-00665
Study First Received: April 23, 2012
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Melanoma
History of Uveal Melanoma
Metastatic
Ipilimumab
Yervoy
BMS-734016
MDX010
Nivolumab
BMS-936558
Opdivo

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Eye Diseases
Eye Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Uveal Diseases

ClinicalTrials.gov processed this record on August 27, 2015