Basal Cell CarcinomaPhase 2NCT03521830
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
A Phase 2 study testing Nivolumab, Ipilimumab and Relatlimab in people with Basal Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Nivolumab, Ipilimumab and Relatlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to Jul 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent
- 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.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
- Type of Participant and Target Disease Characteristics
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic.
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- COHORT A: Patients with advanced BCC who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (nivolumab) alone.
- COHORT B: • Patients with advanced BCC who experience disease progression on anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab) will receive anti-PD-1 (nivolumab) + anti-CTLA-4 (ipilimumab).
- COHORT C: • Patients with advanced BCC who experience disease progression on anti-PD-1 (on or off trial) will receive anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab).
- At least one measurable lesion by the RECIST 1.1 Criteria.
- Participants with Gorlin syndrome will be permitted to enroll in the study.
- Male or female, aged 18 years or older.
- Patients may not have received prior T cell modulating agents for BCC (e.g., anti-CTLA-4, anti-PD-L1, anti-LAG-3, anti-KIR, etc.)
- Laboratory Testing Requirements
- Screening laboratory values obtained within -28 +/- 3 days of first dose must meet the following criteria:
- White Blood Cells greater than or equal to 2000/μL
- Neutrophils greater than or equal to 1500/μL
- Platelets greater than or equal to 100 x 10³/μL
- Hemoglobin greater than or equal to 9.0 g/dL
- 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)
- 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
- 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)
- Reproductive Status
- 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).
- Women must not be breastfeeding.
- 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.
- 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.
- Azoospermic males and those who are continuously not heterosexually active are exempt from contraceptive requirements.
- WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, however they must still undergo pregnancy testing as described in this section.
Who cannot join
- Medical Conditions
- Pregnant or nursing women
- Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.
- 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.
- Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- Viral hepatitis.
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- Participants with active hepatitis B (positive hepatitis B surface antigen [HBsAg] or hepatitis C virus (HCV) (positive HCV RNA) are excluded.
- Patients with past Hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and the absence of HBsAg) are not ineligible, but HBV DNA quantification must be performed and results discussed with the P.I.
- HBV carriers or those participants requiring antiviral therapy are not eligible to participate.
- Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA after discussion with the study P.I.
- Participants with a prior malignancy active within the previous 2 years may be permitted to enroll only after discussion with the study P.I. Examples might include locally curable cancers that have been apparently cured, such as squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Organ transplant recipients with a functioning allograft will be excluded from this study.
- For Cohorts B and C, patients may be excluded from the study if they previously experienced a toxicity to immunotherapy that, in the opinion of the investigator, would make it unsafe to restart therapy. Examples may include a Grade 3 or greater immune mediated adverse event that was considered related to previous immunotherapy and required immunosuppressive therapy, or an immune mediated adverse event that was considered related to previous immunotherapy and is still > grade 1 despite administration of immunosuppressive therapy. Exceptions may include Grade 3 ophthalmologic immune-mediated events that improved to Grade 1 within 2 weeks after topical therapy only, or Grade 3 endocrine immune-mediated events that did not result in symptoms lasting >6 weeks and are not requiring >7.5mg prednisone or equivalent per day.
- For Cohort C, Troponin T (TnT) or I (TnI) > 2 × institutional ULN. Participants with TnT or TnI levels between > 1 to 2 × ULN will be permitted if a repeat levels within 24 hours are ≤ 1 ULN. If TnT or TnI levels are between >1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test will be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation.
- Allergies and Adverse Drug Reaction
- History of severe allergy or hypersensitivity to study drug components.
- 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.
- Other Exclusion Criteria
- Prisoners or participants who are incarcerated may be permitted to enroll only after discussion with the study P.I.
- Participants who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Evan Lipson, MD, 410-502-5977, evanlipson@jhmi.edu
Lisa Kelemen, MSN, RN, 410-614-4618, lkeleme1@jh.edu
About this study
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.
Read the detailed description
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 3 cohorts in a non-randomized fashion according to prior treatment history.
Cohort A: Patients with advanced BCC (aBCC) who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (Nivolumab) alone. Patients will receive Nivolumab 480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles).
Cohort B: Patients with advanced BCC who experience disease progression on anti-PD-1 (Nivolumab) + anti-LAG-3 (Relatlimab) will receive anti-PD-1 (Nivolumab) + anti-CTLA-4 (Ipilimumab). Patients will receive Nivolumab 240mg IV + Ipilimumab 1mg/kg IV every 3 weeks x 4 doses, then Nivolumab 480mg IV every 4 weeks x 7 doses starting 6 weeks after the final dose of Ipilimumab + Nivolumab.
Cohort C: Patients with advanced BCC who experience disease progression on anti-PD-1 (on or off trial) will receive anti-PD-1 (Nivolumab) + anti-LAG-3 (Relatlimab). Patients will receive Nivolumab 480mg IV + Relatlimab 480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles).
Patients enrolled on Cohort A who demonstrate progressive disease after Nivolumab monotherapy may, if appropriate in the opinion of the investigator, move to Cohort B or Cohort C.
Discontinuation of nivolumab or ipilimumab +nivolumab or relatlimab + nivolumab 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Nivolumab, Ipilimumab, Relatlimab
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
480mg IV every 4 weeks
IpilimumabDrug
Also called Yervoy
1mg/kg IV every 4 weeks for 4 doses
RelatlimabDrug
480 mg IV q4wks
| Study group | Role | What they receive |
|---|---|---|
| Previous Systemic Therapy Patients | Active comparator | Cohort A: Nivolumab 480mg IV q4weeks for up to 48 weeks (six 8-week cycles) Receives: Drug: Nivolumab |
| Progression after anti-PD-1 therapy (Cohort A) and Cohort C | Experimental | Cohort B: Nivolumab 240mg IV + ipilimumab 1mg/kg IV q3 weeks x 4 doses, then nivolumab 480mg IV q4 weeks x 7 doses for up to 48 total weeks of therapy. Receives: Drug: Nivolumab; Drug: Ipilimumab |
| Progression after anti-PD-1 therapy (Cohort A) | Experimental | Cohort C: Nivolumab 480 mg IV q4 weeks plus relatlimab 480 mg IV q4 weeks for up to 48 weeks. Receives: Drug: Nivolumab; Drug: Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate per the revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: 5 years
Secondary outcomes (3)
progression-free survival
duration of time from start of treatment to time of progression or Basal Cell Carcinoma specific death, whichever occurs first
Measured: 5 years
duration of response
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
Measured: 5 years
overall survival
measured from the time of enrollment until death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start27 Nov 2018
- Primary completionJul 2027 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Patients from Arm A can crossover to Arm B or Arm C
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Evan J Lipson, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521830
- Sponsor's protocol ID
- J1866
- Other IDs
- IRB00166274, CA209-8DP
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03521830
- Acronym / sponsor ID
- J1866
- Conditions
- Basal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 3 cohorts in a non-randomized fashion according to prior treatment history.
Cohort A: Patients with advanced BCC (aBCC) who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (Nivolumab) alone. Patients will receive Nivolumab 480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles).
Cohort B: Patients with advanced BCC who experience disease progression on anti-PD-1 (Nivolumab) + anti-LAG-3 (Relatlimab) will receive anti-PD-1 (Nivolumab) + anti-CTLA-4 (Ipilimumab). Patients will receive Nivolumab 240mg IV + Ipilimumab 1mg/kg IV every 3 weeks x 4 doses, then Nivolumab 480mg IV every 4 weeks x 7 doses starting 6 weeks after the final dose of Ipilimumab + Nivolumab.
Cohort C: Patients with advanced BCC who experience disease progression on anti-PD-1 (on or off trial) will receive anti-PD-1 (Nivolumab) + anti-LAG-3 (Relatlimab). Patients will receive Nivolumab 480mg IV + Relatlimab 480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles).
Patients enrolled on Cohort A who demonstrate progressive disease after Nivolumab monotherapy may, if appropriate in the opinion of the investigator, move to Cohort B or Cohort C.
Discontinuation of nivolumab or ipilimumab +nivolumab or relatlimab + nivolumab 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients from Arm A can crossover to Arm B or Arm C
| Arm | Type | Receives |
|---|---|---|
| Previous Systemic Therapy Patients | Active comparator | Drug: NivolumabCohort A: Nivolumab 480mg IV q4weeks for up to 48 weeks (six 8-week cycles) |
| Progression after anti-PD-1 therapy (Cohort A) and Cohort C | Experimental | Drug: Nivolumab, Drug: IpilimumabCohort B: Nivolumab 240mg IV + ipilimumab 1mg/kg IV q3 weeks x 4 doses, then nivolumab 480mg IV q4 weeks x 7 doses for up to 48 total weeks of therapy. |
| Progression after anti-PD-1 therapy (Cohort A) | Experimental | Drug: Nivolumab, Drug: RelatlimabCohort C: Nivolumab 480 mg IV q4 weeks plus relatlimab 480 mg IV q4 weeks for up to 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Signed Written Informed Consent
- Type of Participant and Target Disease Characteristics
- Laboratory Testing Requirements
- Screening laboratory values obtained within -28 +/- 3 days of first dose must meet the following criteria:
- Reproductive Status
Key exclusion criteria (20 listed)
- Medical Conditions
- Allergies and Adverse Drug Reaction
- Other Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo480mg IV every 4 weeks | Drug | Previous Systemic Therapy Patients, Progression after anti-PD-1 therapy (Cohort A), Progression after anti-PD-1 therapy (Cohort A) and Cohort C |
| IpilimumabAlso: Yervoy1mg/kg IV every 4 weeks for 4 doses | Drug | Progression after anti-PD-1 therapy (Cohort A) and Cohort C |
| Relatlimab480 mg IV q4wks | Drug | Progression after anti-PD-1 therapy (Cohort A) |
Primary outcome
Objective Response Rate
Time frame: 5 years
Objective response rate per the revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
3 secondary outcomes
progression-free survival
Time frame: 5 years
duration of response
Time frame: 5 years
overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan J Lipson, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Relatlimab in people with Basal Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Kelemen, MSN, RN (410-614-4618, lkeleme1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.