Nivolumab Alone or Plus Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03521830|
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
This is an open-label, phase 2 signal-seeking study.
Screening will begin by establishing a participant's initial eligibility and signing of the informed consent document. Eligible, enrolled patients will be assigned to one of 2 cohorts in a non-randomized fashion according to prior treatment history.
Cohort A: Patients who have not received prior anti-PD-1 therapy, but may have previously experienced progressive disease or intolerance after up to two other systemic therapies (e.g., one or more hedgehog signaling pathway inhibitors) will receive nivolumab 480 mg IV every 4 weeks for up to 48 weeks.
Cohort B: Patients whose disease has progressed after anti-PD-1, either as a part of this trial or outside of this trial, may receive nivolumab 480mg IV q4weeks x 12 doses + ipilimumab 1mg/kg IV q4 weeks x 4 doses, then q12weeks x 2 doses.
Patients enrolled on Cohort A who demonstrate PD after nivolumab monotherapy may, if appropriate in the opinion of the investigator, move to Cohort B.
Discontinuation of nivolumab or ipi+nivo may be at the discretion of the investigator under circumstances including but not limited to the following:
- A complete response to therapy.
- A severe IMAR, defined as Grade 3 or greater.
- Documented disease progression warranting alternative systemic therapy
- Intercurrent illness that prevents further administration of study treatment
- Noncompliance with trial treatment or procedure requirements, or administrative reasons
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Patients from Arm A can crossover to Arm B|
|Masking:||None (Open Label)|
|Official Title:||Nivolumab Alone or Plus Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2026|
Active Comparator: Previous Systemic Therapy Patients
Arm A: Nivolumab 480mg IV q4weeks for up to 48 weeks (six 8-week cycles)
480mg IV every 4 weeks
Other Name: Opdivo
Experimental: Progression after anti-PD-1 therapy
Arm B: ipilimumab 1mg/kg IV q4 weeks x 4 doses + nivolumab 480mg IV q4weeks followed by nivolumab 480mg IV q4weeks for up to 48 total weeks of therapy.
480mg IV every 4 weeks
Other Name: Opdivo
1mg/kg IV every 4 weeks for 4 doses
Other Name: Yervoy
- Objective Response Rate [ Time Frame: 5 years ]Objective response rate per the revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- progression-free survival [ Time Frame: 5 years ]duration of time from start of treatment to time of progression or Basal Cell Carcinoma specific death, whichever occurs first
- duration of response [ Time Frame: 5 years ]duration of time that measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
- overall survival [ Time Frame: 5 years ]measured from the time of enrollment until death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521830
|Contact: Trish Brothers, R.N., B.S.N.||firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Evan Lipson, MD 410-502-5977 email@example.com|
|Contact: Trish Brothers, RN, BSN 410-955-6605 firstname.lastname@example.org|
|Principal Investigator: Evan Lipson, MD|
|Principal Investigator:||Evan J Lipson, M.D.||Johns Hopkins University|