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Checkpoint Inhibitor

Nivolumab for Pancreatic Tumors (CheckMate 848 Trial)

Phase 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization up to 42 months
Awards & highlights

CheckMate 848 Trial Summary

This trial will test if a combination of two drugs can work better than either drug alone in people with different types of cancer.

Eligible Conditions
  • Pancreatic Tumor

CheckMate 848 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up to 42 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
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
Secondary outcome measures
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Clinical Benefit Rate (CBR) Per Investigator
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
+10 more

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%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Hypercalcaemia
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

CheckMate 848 Trial Design

2Treatment groups
Experimental Treatment
Group I: Nivolumab MonotherapyExperimental Treatment1 Intervention
Group II: Nivolumab + Ipilimumab CombinationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,288 Total Patients Enrolled

Frequently Asked Questions

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

Nivolumab has received FDA approval, correct?

"Nivolumab's safety is only supported by some data, as this is a Phase 2 trial. Consequently, it received a score of 2."

Answered by AI

What other investigations have included Nivolumab in their analysis?

"As of right now, there are 796 different ongoing trials related to Nivolumab. Out of these, 86 have entered Phase 3 clinical testing. The majority of the research is being conducted in Pittsburgh, Pennsylvania; however,43300 other locations across the globe are also running similar studies."

Answered by AI

Are there any unfilled positions for participants in this research project?

"As of now, this specific trial is not recruiting patients. It was initially posted on October 31st, 2018 and was last updated over 4 months ago on July 26th, 2022. Although this research project isn't taking any more volunteers, there are 3258 other clinical trials that are currently looking for participants."

Answered by AI

Is this research project being conducted at several facilities within the city limits?

"There are 24 sites where this study is being conducted, some of which include Texas Oncology in Dallas, Oregon Health & Science University in Portland, and Texas Oncology, PA - Central Austin Cancer Center in Austin."

Answered by AI

Can you give some examples of conditions that Nivolumab is effective against?

"Nivolumab is not only used as a treatment for previous anti-angiogenic therapy, but also unresectable melanoma, squamous cell carcinoma, and other malignant neoplasms."

Answered by AI

How many people are expected to enroll in this trial before it is completed?

"Unfortunately, this clinical trial is no longer actively enrolling patients. The study was initially posted on October 31st, 2018 and had its last update on July 26th, 2022. However, if you are still seeking to participate in a trial, there are currently 2462 studies related to cancer and 796 for Nivolumab that are looking for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
2018. "A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03668119.
~33 spots leftby Apr 2025
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