NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

Alliance A091401 - "RANDOMIZED PHASE II STUDY OF NIVOLUMAB WITH OR WITHOUT IPILIMUMAB IN PATIENTS WITH METASTATIC OR UNRESECTABLE SARCOMA"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please contact NCORP-KC for complete protocol information.



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Sarcoma Clinical Trial

CANCER TYPE: Sarcoma
RESEARCH BASE: Alliance
NCT NUMBER: NCT02500797
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Stage IV or unresectable, measureable sarcoma, ≥ 1 prior systemic therapy, nivolumab vs. nivolumab + ipilimumab,



NOTES


Patients must have a FFPE tumor block OR 1 representative H&E and 20 unstained sarcoma tissue slides available for submission for central pathology review. This review ismandatory prior to registration to confirm eligibility.

Treatment   (Supplied Drug:  nivolumab and ipilimumab)

Protocol treatment is to begin ≤ 14 days of registration.

Arm 1:

Nivolumab 3mg/kg IV every 2 weeks for 104 weeks, or until progression or toxicity occurs

Arm 2:

Nivolumab 3mg/kg IV  AND

Ipilimumab 1mg/kg every 3 weeks for 104 weeks, or until progression or toxicity occurs

1 cycle = 6 weeks

Upon progression on a minimum of 10 weeks of nivolumab single agent, patients may crossover to dual agent therapy.



ELIGIBILITY

Pre-Registration

  • Central pathology review submission.  Patients must have a FFPE tumor block OR 1 representative H&E and 20 unstained sarcoma tissue slides available for submission for central pathology review. This review ismandatory prior to registration to confirm eligibility. See Section 6.2 for details on slide/block submission.

Registration

  • Patients must have histologically confirmed LPS (only dedifferentiated and pleomorphic. Well differentiated not eligible), UPS/MFH, or GIST.
  • Measurable disease as defined in Section 11.0. 
  • Locally advanced/unresectable or metastatic disease.
  • ≥ 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy.
  • No prior therapy with ipilimumab or nivolumab, or any agent targeting PD-1, PD-L1 or CTLA-4.
  • No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration. For GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment.
  • Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade 1 or less.
  • No history of the following:
    • Active known or suspected autoimmune disease. See Appendix IV for details.
    • Patients with HIV are eligible if the lymphocytes > 350 CD4+ cells and no detectable viral load
    • Symptomatic, untreated, or uncontrolled brain metastases present.
    • Active autoimmune colitis
    • Autoimmune panhypopituitarism
    • Autoimmune adrenal insufficiency
    • Known active hepatitis B:
      • HBsAg > 6 months
      • Serum HBV DNA 20,000 IU/ml (105copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in HBeAg-negative chronic hepatitis B
      • Persistent or intermittent elevation in ALT/AST levels
      • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
    • Known active hepatitis C:
      • Hepatitis C AB positive
      • Presence of HCV RNA
    • Known active pulmonary disease with hypoxia defined as
      • Oxygen saturation < 85% on room air or
      • Oxygen saturation <88% despite supplemental oxygen
  • No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration.
  • Not pregnant and not nursing
  • Age ≥ 18 years
  • ECOG Performance Status 0 or 1.
  • Required Initial Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
    • Platelet Count ≥ 100,000/mm3
    • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR
    • Calc. Creatinine Clearance > 45 mL/min
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • AST / ALT ≤ 3 x upper limit of normal (ULN)
    • TSH WNL

Re-Registration for Crossover Patients

  • Measurable disease as defined in Section 11.0.
  • Locally advanced/unresectable or metastatic disease.
  • Patient MUST have had progressive disease (radiographic or clinical) while on arm 1 single agent nivolumab while registered to A091401.
  • Patients removed from any immunotherapy for reasons other than progressive disease, including arm 1 single agent nivolumab of A091401, are NOT eligible for reregistration
  • Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration
  • Patients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) ≤ 12 months of re-registration to crossover dual agent therapy
  • No treatment with immunotherapy ≤ 21 days before re-registration. No treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before re-registration.
  • No treatment with nitrosourea or mitomycin ≤ 42 days before re-registration.
  • Patients should have resolution of any toxic effects of prior therapy (except fatigue and alopecia) to NCI CTCAE, Version 4.0, grade 1 or less, including immune toxicity.
  • No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of re-registration.
  • Not pregnant and not nursing
  • ECOG Performance Status 0 or 1.
  • Required Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
    • Platelet Count ≥ 100,000/mm3
    • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR
    • Calc. Creatinine Clearance > 45 mL/min
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • AST / ALT ≤ 3 x upper limit of normal (ULN)
    • TSH WNL
       





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