Phase I/II Study of Nivolumab in Combination With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

Who is this study for? Adult patients with Hodgkin's Lymphoma
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

• Age ≥ 18 years at the time of consent.

• ECOG Performance Status of 0, 1 or 2.

• Histologically confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or refractory - historical biopsy at last relapse is acceptable. NOTE: a repeat biopsy is not required for Phase I if the historical biopsy was performed at the most recent relapse, without remission in between. A fresh biopsy is not required for Phase II.

• Presence of radiographically measurable disease (defined as the presence one or more ≥ 1.5 cm lesions, as measured in the longest dimension by PET/CT) within 4 weeks of study registration.

• Prior therapy with check-point inhibitors (nivolumab, pembrolizumab, others) and subsequent progressive disease, stable disease or mixed response

• Failed at least 2 prior therapies including cytotoxic chemotherapy including ABVD or similar, autologous transplantation, brentuximab vedotin, allogenic transplantation without active graft versus host disease Note: Patients who are eligible and willing to undergo autologous transplant should not be enrolled on this trial

• Prior cancer treatment must be completed at least 14 days prior to registration and the patient must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline. Radiation therapy must be completed at least 7 days prior to registration.

• Absolute Neutrophil Count ≥ 1000/μL

• Platelets ≥ 75,000/μL (or ≥50,000/mm3 if known BM involvement)

• Calculated creatinine clearance ≥ 40 cc/min using the Cockcroft-Gault formula

• Bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) ≤ 2.5 × ULN

• Alanine aminotransferase (ALT) ≤ 2.5 × ULN

• Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months

• Males who are sexually active with partners of child-bearing potential must be willing to abstain from heterosexual activity or adhere to contraception from the time of written consent until 7 months after treatment discontinuation.

• Patient must provide voluntary written informed consent prior to the performance of any research related tests or procedures.

Locations
United States
Iowa
University of Iowa Hospitals and Clinics
ACTIVE_NOT_RECRUITING
Iowa City
Illinois
University of Illinois Cancer Center
COMPLETED
Chicago
Indiana
Indiana Melvin and Bren Simon Comprehensive Cancer Center
WITHDRAWN
Indianapolis
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Veronika Bachanova
bach0173@umn.edu
612-625-5469
Backup
Ahran Lee
alee@hoosiercancer.org
317-634-5842
Time Frame
Start Date: 2018-09-13
Estimated Completion Date: 2027-07
Participants
Target number of participants: 54
Treatments
Experimental: Phase I:Ruxolitinib and Nivolumab
Participants will receive ruxolitinib at their assigned dose taken orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.
Experimental: Phase II: Ruxolitinib and Nivolumab
Participants will receive ruxolitinib at 20mg orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.
Authors
Umar Faroog, David Peace
Sponsors
Collaborators: Bristol-Myers Squibb, Incyte Corporation
Leads: Veronika Bachanova

This content was sourced from clinicaltrials.gov