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Checkpoint Inhibitor

Nivolumab for Cancer (CheckMate358 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dosing date to the date of death (up to 83 months)
Awards & highlights

CheckMate358 Trial Summary

This trial is investigating the safety and effectiveness of nivolumab and nivolumab combination therapy in patients with virus-associated tumors. The study will enroll patients with anal canal cancer, cervical cancer, Epstein Barr Virus-positive gastric cancer, Merkel Cell cancer, penile cancer, vaginal and vulvar cancer, nasopharyngeal cancer, and head and neck cancer.

CheckMate358 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dosing date to the date of death (up to 83 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dosing date to the date of death (up to 83 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
+1 more
Secondary outcome measures
Metastatic: Investigator-Assessed Duration of Response (DoR)
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Metastatic: Overall Survival (OS)

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%
Hypomagnesaemia
19%
Headache
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%
Hyperglycaemia
7%
Bronchitis
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperkalaemia
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Hypotension
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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Femur fracture
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Pneumothorax
1%
Hypercalcaemia
1%
Small intestinal haemorrhage
1%
Bone pain
1%
Superior vena cava syndrome
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Syncope
1%
Confusional state
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

CheckMate358 Trial Design

5Treatment groups
Experimental Treatment
Group I: Nivolumab plus Relatlimab CohortExperimental Treatment2 Interventions
Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified ** Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort
Group II: Nivolumab plus Ipilimumab CohortExperimental Treatment2 Interventions
Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified **Not participating: Belgium, France and Germany Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico **Not participating in cohort expansion: France, Germany, Korea and Taiwan
Group III: Nivolumab plus Daratumumab CohortExperimental Treatment2 Interventions
Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified **Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort
Group IV: Neoadjuvant CohortExperimental Treatment1 Intervention
Nivolumab intravenous infusion as specified **Not participating: Japan, Korea, and Taiwan
Group V: Metastatic Monotherapy CohortExperimental Treatment1 Intervention
Nivolumab intravenous infusion as specified
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Ipilimumab
2014
Completed Phase 3
~2670
Relatlimab
2018
Completed Phase 2
~1110
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,635 Previous Clinical Trials
4,126,301 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,945 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal for ImmunoTherapy of CancerJournal
Fatal Enteric Plexus Neuropathy After One Dose of Ipilimumab Plus Nivolumab: A Case Report
Appelbaum, Jacob, David Wells, Joseph B. Hiatt, Gideon Steinbach, F. Marc Stewart, Hannah Thomas, Paul Nghiem, Raj P. Kapur, John A. Thompson, and Shailender Bhatia. 2018. “Fatal Enteric Plexus Neuropathy After One Dose of Ipilimumab Plus Nivolumab: A Case Report”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1186/s40425-018-0396-9.
Journal of Clinical OncologyJournal
Neoadjuvant Nivolumab for Patients with Resectable Merkel Cell Carcinoma in the Checkmate 358 Trial
Topalian, Suzanne L., Shailender Bhatia, Asim Amin, Ragini R. Kudchadkar, William H. Sharfman, Celeste Lebbé, Jean-Pierre Delord, et al.. 2020. “Neoadjuvant Nivolumab for Patients with Resectable Merkel Cell Carcinoma in the Checkmate 358 Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.00201.
Journal for ImmunoTherapy of CancerJournal
Neoadjuvant Nivolumab for Patients with Resectable Hpv-positive and Hpv-negative Squamous Cell Carcinomas of the Head and Neck in the Checkmate 358 Trial
Ferris, Robert L, William C Spanos, Rom Leidner, Anthony Gonçalves, Uwe M Martens, Chrisann Kyi, William Sharfman, et al.. 2021. “Neoadjuvant Nivolumab for Patients with Resectable Hpv-positive and Hpv-negative Squamous Cell Carcinomas of the Head and Neck in the Checkmate 358 Trial”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2021-002568.
Journal of Clinical OncologyJournal
Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results from the Phase I/II Checkmate 358 Trial
Naumann, R. Wendel, Antoine Hollebecque, Tim Meyer, Michael-John Devlin, Ana Oaknin, Joseph Kerger, Jose M. López-Picazo, et al.. 2019. “Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results from the Phase I/II Checkmate 358 Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.00739.
~61 spots leftby Apr 2025
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