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Checkpoint Inhibitor

Nivolumab +/− Relatlimab/Ipilimumab for Skin Cancer

Phase 2
Recruiting
Led By Evan J Lipson, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically confirmed Basal Cell Carcinoma with disease considered unresectable or metastatic
Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it works better than existing treatments for a specific type of skin cancer.

Who is the study for?
Adults with advanced basal cell carcinoma (BCC) that can't be surgically removed or has spread, who haven't had systemic BCC treatment or have tried a specific immunotherapy without success. Participants need normal organ function and blood counts, not be pregnant or breastfeeding, agree to contraception use, and must not have HIV/AIDS, active hepatitis B/C, severe allergies to trial drugs, certain other cancers within the last 2 years, unstable brain metastases, or require high-dose steroids.Check my eligibility
What is being tested?
The phase 2 trial is testing Nivolumab alone or combined with Relatlimab or Ipilimumab in treating unresectable/metastatic BCC. It aims to find out how well these treatments work for patients who either haven't received prior systemic therapy for BCC or whose disease didn’t respond to previous anti-PD-(L)1 monotherapy.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the liver and intestines; skin issues; hormone gland problems (like thyroid); infusion reactions during drug administration; fatigue; and potentially serious infections due to weakened immune defenses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Basal Cell Carcinoma that cannot be removed by surgery or has spread.
Select...
I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
duration of response
overall survival
progression-free survival

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Progression after anti-PD-1 therapy (Cohort A) and Cohort CExperimental Treatment2 Interventions
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.
Group II: Progression after anti-PD-1 therapy (Cohort A)Experimental Treatment2 Interventions
Cohort C: Nivolumab 480 mg IV q4 weeks plus relatlimab 480 mg IV q4 weeks for up to 48 weeks.
Group III: Previous Systemic Therapy PatientsActive Control1 Intervention
Cohort A: Nivolumab 480mg IV q4weeks for up to 48 weeks (six 8-week cycles)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1120

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,407 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,863 Total Patients Enrolled
Evan J Lipson, M.D.Principal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03521830 — Phase 2
Basal Cell Carcinoma Research Study Groups: Progression after anti-PD-1 therapy (Cohort A) and Cohort C, Previous Systemic Therapy Patients, Progression after anti-PD-1 therapy (Cohort A)
Basal Cell Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03521830 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03521830 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what ways has Nivolumab been employed to treat patients?

"Nivolumab is frequently administered after anti-angiogenic treatments and can be prescribed to treat afflictions such as malignant neoplasms, inoperable melanoma, and squamous cell carcinoma."

Answered by AI

Is the recruitment process for this clinical trial still ongoing?

"The active recruitment for this clinical trial is evident by the data hosted on clinicaltrials.gov, which records an initial post date of 11/27/2018 and a most recent update from 3/10/2022."

Answered by AI

Has Nivolumab been the focus of any prior experiments?

"Currently, there are 766 active studies being conducted on Nivolumab with 86 of those trials in their third phase. Pittsburgh, Pennsylvania has several research sites dedicated to the drug's development; however, 42717 locations globally have access to clinical trial data for this medication."

Answered by AI

How many individuals are enrolled in this investigation?

"Affirmative. According to clinicaltrials.gov, this medical research is actively seeking enrollees -- it was originally posted on November 27th 2018 and updated most recently on March 10th 2022. Currently, 40 patients need to be accepted at a single site for the trial to move forward."

Answered by AI

Are there any hazards associated with the use of Nivolumab?

"This Phase 2 trial does not possess clinical evidence of efficacy, thus the safety rating for Nivolumab was appraised as a two."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
2018. "Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03521830.
~14 spots leftby Mar 2026
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