NCT04050462
Terminated
Phase 2
A Phase II, Randomized, Controlled Trial of Nivolumab in Combination With BMS-986253 in Advanced Hepatocellular Carcinoma (HCC) Patients
ConditionsHepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Objective Response Rate (ORR)
Overview
Brief Summary
A phase II clinical trial is utilized to examine whether BMS-986253 (25 subjects) or Cabiralizumab (25 subjects) when combined with Nivolumab offers improved radiographic objective response rates (ORR) over Nivolumab monotherapy (25 subjects) in advanced HCC patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have histologically confirmed evidence of HCC, Childs-Pugh score of ≤
- •a. Participants must be willing to provide specimen from fresh, pre- and on-treatment tumor core biopsies for histologic diagnosis and translational studies.
- •Radiographically measurable disease by RECIST1.1 in at least one site.
- •Deemed to not be a candidate for resection or other local-regional therapy.
- •Must not be receiving treatment with other investigational agents and must not have received any other systemic therapy prior to registration.
- •a. Prior radioembolization, local ablative therapies (radiofrequency, microwave or cryoablation), radiation (external beam or stereotactic), or hepatic resection permitted if completed ≥ 4 weeks prior to study enrollment and if patient has recovered with ≤ grade 1 toxicity and if untreated measurable disease is present.
- •Be willing and able to provide written informed consent/assent for the trial.
- •Participants must be ≥ 18 years
- •Have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •If hepatitis B is present, participants must be on anti-viral HBV therapy.
Exclusion Criteria
- •Women who are pregnant or breastfeeding.
- •Presence of other malignancies. Participants with active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ. NOTE: Patients with history of malignancy are not considered to have a "currently active" malignancy if they have completed therapy and are now considered by their physician to be at less than 30% risk for relapse.
- •Have active or history of Tuberculosis
- •Participants with known HIV positive status
- •Participants with known CNS metastases
- •Uncontrolled ascites
- •Uncontrolled encephalopathy
- •Uncontrolled gastro-esophageal varicesPrior organ allograft or allogeneic bone marrow transplantation
- •Participants with active, known, or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration except for adrenal replacement steroid doses \> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: Treatment with a short course of steroids (\< 5 days) up to 7 days prior to initiating study treatment is permitted.
Arms & Interventions
Nivolumab Monotherapy
Active Comparator
Intervention: Nivolumab 240 mg IV every 2 weeks (Drug)
Nivolumab/BMS-986253 combination
Experimental
Intervention: Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks (Drug)
Nivolumab/BMS-986253 combination
Experimental
Intervention: Nivolumab 240 mg IV every 2 weeks (Drug)
Nivolumab/Cabiralizumab combination
Experimental
Intervention: Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks (Drug)
Nivolumab/Cabiralizumab combination
Experimental
Intervention: Nivolumab 240 mg IV every 2 weeks (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years)
ORR is measured as the percentage of people in a study or treatment group who have a partial response or complete response to the treatment. ORR will be determined based upon RECIST v. 1.1 criteria. Per RECIST v. 1.1 criteria, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesions, compared to the baseline.
Secondary Outcomes
- Progression Free Survival (PFS)(From date of treatment until the date of first documented progression (assessed up to 5 years))
- Overall Survival (OS)(From date of treatment until the date of death from any cause (assessed up to 5 years))
- Time to Response (TTR)(From treatment initiation until first sign of response (up to 5 years))
- Disease Control Rate (DOR)(Through study completion (assessed up to 5 years))
Investigators
Study Sites (2)
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