Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure

NCT02864316 | Terminated Phase 2 Results DMC

• 2 other identifiers: J1695IRB00105682
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.

Conditions

Solid Tumors Induced by Prior Radiation Exposure

Keywords

radiation-induced solid tumors; Nivolumab; Phase 2 study

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Rate

  Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

  Up to 24 weeks

Secondary Outcomes (5)

• Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment

  24 weeks

• Progression-free Survival

  Up to 22 months

• Duration of Response

  Up to 22 months

• Number of Participants With Treatment-related Adverse Events

  up to 100 days post-intervention

• Overall Survival

  Up to 22 months

Study Arms (2)

Radiation-Induced Metastatic Sarcoma

EXPERIMENTAL

a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Drug: Nivolumab

Radiation-Induced Non-Sarcoma Metastatic Solid Tumors

EXPERIMENTAL

a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Drug: Nivolumab

Interventions

Nivolumab DRUG

Also known as: BMS-936558, MDX-1106

Radiation-Induced Metastatic Sarcoma; Radiation-Induced Non-Sarcoma Metastatic Solid Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic or unresectable solid tumor which standard curative or palliative measures do not exist or are no longer effective. The primary site of the metastatic or unresectable tumor must have arisen within a previously irradiated site and be considered a radiation-induced tumor.
• Pre-treatment tumor specimen available. Patients with no available archived specimen must be willing to undergo a pre-treatment tumor biopsy.
• Measurable disease.
• Progressive disease on study entry.
• Received adjuvant or neoadjuvant chemotherapy and developed recurrent or metastatic disease within 6 months of completing therapy.
• Age \>18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \<2.
• Life expectancy of greater than 3 months.
• Adequate organ and marrow function as defined below:
• White Blood Cell \>2,000/per microliter
• Absolute neutrophil count \>1,500/per microliter
• Platelets \>100,000/per microliter
• Hemoglobin ≥9.0 g/dL
• Total bilirubin ≤1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
• Aspartate Aminotransferase(SGOT)/Alanine Aminotransferase (SGPT) \<3 X institutional ULN

You may not qualify if:

• Any active, known or suspected autoimmune disease.
• Requiring continuous supplemental oxygen.
• Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or unresolved toxicity due to agents administered more than 2 weeks earlier.
• Uncontrolled brain metastases.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
• Uncontrolled inter-current illness.
• Pregnant or currently breastfeeding.
• Receiving any other anticancer therapy.
• Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA- 4 antibody therapies, any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
• History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating ongoing acute or chronic infection.
• Requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sidney Kimmel Cancer Center @ Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Patrick Forde, MBBCh
• Organization: Sidney Kimmel Comprehensive Cancer Center

pforde1@jhmi.edu

410-955-3974

Study Officials

• Patrick Forde, MB, BCH

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 12, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)