RECRUITING

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.

Official Title

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Quick Facts

Study Start:2018-11-27

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03521830

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed Written Informed Consent 1. Subjects must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. 2. Type of Participant and Target Disease Characteristics 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 2. Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic. 3. Laboratory Testing Requirements 1. White Blood Cells greater than or equal to 2000/μL 2. Neutrophils greater than or equal to 1500/μL 3. Platelets greater than or equal to 100 x 10³/μL 4. Hemoglobin greater than or equal to 9.0 g/dL 5. Serum creatinine less than or equal to 1.5 x Upper Limit of Normal (ULN)or creatinine clearance (CrCl) greater than or equal to 40 mL/minute (using Cockcroft/Gault formula) 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN, except in patients with liver metastases whose values may be less than or equal to 5 x ULN 7. Total Bilirubin less than or equal to 1.5 x ULN (except subjects with Gilbert Syndrome who may have total bilirubin less than or equal to 3.0 mg/dL) 4. Reproductive Status 1. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the initial administration of study drug, then every 4 weeks +/- 1 week thereafter for the duration of treatment with study drug(s). 2. Women must not be breastfeeding. 3. WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion. 4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion. 5. Azoospermic males and those who are continuously not heterosexually active are exempt from contraceptive requirements. 6. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, however they must still undergo pregnancy testing as described in this section.	1. Medical Conditions 1. Pregnant or nursing women 2. Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy. 3. Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I. 4. Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). 5. Viral hepatitis. 2. Allergies and Adverse Drug Reaction 1. History of severe allergy or hypersensitivity to study drug components. 2. Patients with a history of a severe toxicity to an immune checkpoint blocking drug may be permitted to enroll only after discussion with the study P.I. 3. Other Exclusion Criteria 1. Prisoners or participants who are incarcerated may be permitted to enroll only after discussion with the study P.I. 2. Participants who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Inclusion Criteria

Exclusion Criteria

1. Signed Written Informed Consent
1. Subjects must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
2. Type of Participant and Target Disease Characteristics
1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
2. Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic.
3. Laboratory Testing Requirements
1. White Blood Cells greater than or equal to 2000/μL
2. Neutrophils greater than or equal to 1500/μL
3. Platelets greater than or equal to 100 x 10³/μL
4. Hemoglobin greater than or equal to 9.0 g/dL
5. Serum creatinine less than or equal to 1.5 x Upper Limit of Normal (ULN)or creatinine clearance (CrCl) greater than or equal to 40 mL/minute (using Cockcroft/Gault formula)
6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN, except in patients with liver metastases whose values may be less than or equal to 5 x ULN
7. Total Bilirubin less than or equal to 1.5 x ULN (except subjects with Gilbert Syndrome who may have total bilirubin less than or equal to 3.0 mg/dL)
4. Reproductive Status
1. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the initial administration of study drug, then every 4 weeks +/- 1 week thereafter for the duration of treatment with study drug(s).
2. Women must not be breastfeeding.
3. WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion.
4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion.
5. Azoospermic males and those who are continuously not heterosexually active are exempt from contraceptive requirements.
6. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, however they must still undergo pregnancy testing as described in this section.

1. Medical Conditions
1. Pregnant or nursing women
2. Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.
3. Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I.
4. Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
5. Viral hepatitis.
2. Allergies and Adverse Drug Reaction
1. History of severe allergy or hypersensitivity to study drug components.
2. Patients with a history of a severe toxicity to an immune checkpoint blocking drug may be permitted to enroll only after discussion with the study P.I.
3. Other Exclusion Criteria
1. Prisoners or participants who are incarcerated may be permitted to enroll only after discussion with the study P.I.
2. Participants who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Contacts and Locations

Study Contact

Alice Pons, R.N., B. S, B.S.N.

CONTACT

410-502-9380

Ponsal@jhmi.edu

Principal Investigator

Evan J Lipson, M.D.

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital

Baltimore, Maryland, 21231

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Evan J Lipson, M.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Registration Dates

Study Start Date2018-11-27

Study Completion Date2027-03

Study Record Updates

Study Start Date2018-11-27

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Basal Cell Carcinoma