- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518958
A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab (PRIMETIME)
November 14, 2019 updated by: EpicentRx, Inc.
A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety and Tolerability of RRx-001 and Nivolumab in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Life-Prolonging Therapies (PRIMETIME)
This is a dose escalation protocol to determine the feasibility of co-administration of RRx-001 and nivolumab.
Immune surveillance is an endogenous mechanism to cause remission of neoplastic growth.
Epigenetic agents like RRx-001 are associated not only with enhanced gene transcription and restored expression of silenced genes but also with increased expression of pro-inflammatory mediators, upregulation of PD-L1 on tumor cells and de-repression of antigens that promote immune recognition of tumors.
It is hypothesized that RRx-001, will prime or sensitize to immune checkpoint therapy targeting PD-1 interaction with nivolumab.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label dose escalation study, consisting of the following periods:
- 1) Screening Period (Up to 16 days): Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfillment of eligibility criteria. Potential participants are required to provide written informed consent prior to the performance of any study specific Screening procedures.
- 2) Treatment Period (Day 1 to 57): Between 15 and 45 eligible male and female adult subjects will receive weekly RRx-001 for a total of nine doses and every other week nivolumab for a total of 5 doses (odd cycles) or 4 doses (even cycles). Study medication (RRx-001 and nivolumab) will be administered intravenously at the study center. The Treatment Period will end following the last dose of nivolumab. Subjects will attend the study center weekly for on-study assessments.
- 3) Follow-up Period: Subjects that have completed nivolumab dosing will undergo a follow-up assessment monthly, up to 100 days, for the emergence of delayed toxicity with particular attention to delayed immune related toxicities.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20889
- Walter Reed National Military Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) or lymphoma that are either refractory or is intolerant to, or has refused all standard available life-prolonging therapies.
- Measurable or evaluable disease based on RECIST criteria version. 1.1.
- ECOG performance status is 0-2 at Screening.
- Acceptable liver function at Screening,
- Serum creatinine < 2x institution upper limit of normal
- Acceptable hematologic status at Screening
- Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
Exclusion Criteria:
- Serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
- If female, subject is pregnant and/or breastfeeding.
- Subjects with active autoimmune disease or history of autoimmune disease that might recur and may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
- Subjects having a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, and anti-CD40 antibodies. However, prior exposure to RRx-001 is allowed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RRx-001 + Nivolumab
Patients enrolled in this trial will receive study drug (RRx-001) on Day 1 as a single agent.
Nivolumab (3 mg/kg) will be administered on Day 2 or Day 3 as a single agent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number, frequency and type of adverse events
Time Frame: 23 weeks
|
23 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 2 years
|
2 years
|
|
Time to Tumor Progression (TTP)
Time Frame: 23 weeks
|
Time to Tumor Progression (TTP) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria
|
23 weeks
|
Clinical benefit Rate
Time Frame: 23 weeks
|
Duration of clinical benefit (Stable disease or better) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria
|
23 weeks
|
Progression-Free Survival (PFS)
Time Frame: 23 weeks
|
Progression-Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors [RECIST v1.1] criteria
|
23 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2015
Primary Completion (Actual)
May 17, 2016
Study Completion (Actual)
September 12, 2016
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 5, 2015
First Posted (Estimate)
August 10, 2015
Study Record Updates
Last Update Posted (Actual)
November 18, 2019
Last Update Submitted That Met QC Criteria
November 14, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRx001-14-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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