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Trial record 4 of 8 for:    lirilumab

Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02599649
First received: November 5, 2015
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied.

Condition Intervention Phase
Leukemia Drug: Lirilumab Drug: Nivolumab Drug: Azacitidine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Combination of Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: 116 days ]
    Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria used to assess response.


Estimated Enrollment: 80
Actual Study Start Date: March 21, 2016
Estimated Study Completion Date: March 2025
Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low or Intermediate-1 MDS Group - Lirilumab
Lirilumab by vein over about 60 minutes 1 time each 28 day cycle.
Drug: Lirilumab
3 mg/kg by vein every 4 weeks.
Experimental: Low or Intermediate-1 MDS Group - Nivolumab + Lirilumab
Nivolumab by vein over about 60 minutes every 2 weeks during Cycles 1-9. Lirilumab by vein over about 60 minutes 1 time each cycle. Cycle is 28 days.
Drug: Lirilumab
3 mg/kg by vein every 4 weeks.
Drug: Nivolumab
3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.
Other Names:
  • BMS-936558
  • Opdivo
Experimental: High Risk MDS Group - Azacitidine + Lirilumab
Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle.
Drug: Lirilumab
3 mg/kg by vein every 4 weeks.
Drug: Azacitidine
75 mg/m^2 by vein for 7 days of a 28 day cycle.
Other Names:
  • 5-azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
  • Azacytidine
Experimental: High Risk MDS Group - Azacitidine + Lirilumab + Nivolumab
Azacitidine by vein over about 60 minutes on Days 1-7 of each 28 day cycle. Lirilumab by vein over about 60 minutes on Day 7 of each 28 day cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, Nivolumab by vein over about 60 minutes.
Drug: Lirilumab
3 mg/kg by vein every 4 weeks.
Drug: Nivolumab
3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.
Other Names:
  • BMS-936558
  • Opdivo
Drug: Azacitidine
75 mg/m^2 by vein for 7 days of a 28 day cycle.
Other Names:
  • 5-azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
  • Azacytidine

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients with MDS (up to 20% blasts) of any risk. Patients with lower risk MDS (low and int-1 by IPSS) could have received prior non-hypomethylating agent therapy (ie growth factors or lenalidomide). Patients with higher risk MDS (int-2 or high by IPSS) should not have received prior therapy with a hypomethylating agent.
  2. Age 18 years or older.
  3. Adequate organ function: creatinine </=2.5 x ULN; serum bilirubin </=2.5 x ULN; AST and ALT </=2.5 x ULN.
  4. ECOG performance status </=2.
  5. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
  6. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks after the last dose of nivolumab.
  7. Patients or their legally authorized representative must provide written informed consent.

Exclusion Criteria:

  1. History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
  2. Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs.
  3. Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
  4. Patients unwilling or unable to comply with the protocol.
  5. Patients who are on high dose steroid (ie prednisone or equivalent more than 10 mg a day) or immune suppression medications.
  6. Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]).
  7. Patients with a history of Inflammatory Bowel Disease such as Crohn's disease and ulcerative colitis
  8. Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months) or with a history of HIV disease.
  9. Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.
  10. Females who are pregnant or lactating
  11. Prior treatment with stem cell transplantation.
  12. Prohibited Prior Treatments and/or Therapies: a) Prior therapy with an anti-KIR, anti-PD-1, or anti-PD-L1, antibody. b) Prior treatment regimens with any immune cell modulating antibody such as anti-CD137 and anti-OX40. However, prior anti-CTLA4 therapy is allowed if the last dose is 101 days or more from the first dose of study drug. c) Exposure to any other investigational drug within 2 weeks prior to the first dose of study drug (within 101 days for anti-CTLA4 therapy). d) Any anti-cancer therapy (e.g., chemotherapy, biologics, vaccines, radiotherapy with curative intent, or hormonal treatment) within 2 weeks prior to the first dose of study drug administration (within 101 days for anti-CTLA4 therapy administration.
  13. Continued from #12: e) Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to study drug. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed. f) Systemic corticosteroid at immunosuppressive doses (> 10 mg/day of prednisone or equivalent), must be discontinued at least 2 weeks prior to enrollment.
  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: NCT02599649

Contacts
Contact: Guillermo Garcia-Manero, MD 713-745-3428

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: Guillermo Garcia-Manero, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02599649     History of Changes
Other Study ID Numbers: 2014-0934
NCI-2015-02120 ( Other Identifier: NCI CTRP )
Study First Received: November 5, 2015
Last Updated: June 7, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lirilumab
Myelodysplastic syndrome
MDS
Low or intermediate-1 MDS
High Risk MDS
Nivolumab
BMS-936558
Opdivo
Azacitidine
5-azacytidine
5-aza
Vidaza
5-AZC
AZA-CR
Ladakamycin
NSC-102816
Azacytidine

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Nivolumab
Azacitidine
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 22, 2017