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Virus Therapy
CMP-001 + Nivolumab for Melanoma
Phase 2
Waitlist Available
Led By Diwakar Davar, MD
Research Sponsored by Diwakar Davar
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 3 years
Awards & highlights
Study Summary
This trial is testing if nivolumab + CMP-001 is better than nivolumab alone at destroying disease in the lymph node.
Who is the study for?
This trial is for adults over 18 with Stage IIIB/C/D melanoma and visible lymph node disease. Participants must have good organ function, measurable disease, be willing to undergo a biopsy, and not be on high-dose steroids or have certain lung conditions. Women of childbearing age must use birth control or abstain from sex.Check my eligibility
What is being tested?
The study tests if combining CMP-001 with Nivolumab can better eliminate melanoma in the lymph nodes compared to current treatments. Patients will receive both drugs and their response rate will be measured according to specific criteria.See study design
What are the potential side effects?
Potential side effects include typical reactions associated with immunotherapy such as fatigue, skin reactions, inflammation of organs (like lungs), potential hormonal changes, flu-like symptoms, and an increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Pathologic Response Rate (MPR)
Secondary outcome measures
12-month Overall Survival (OS)
12-month Relapse-free Survival
24-month Overall Survival (OS)
+6 moreOther outcome measures
Expression of Inhibitory and Activating Receptors and Ligands
Genetic and Transcriptomic Signatures of Response/Non-response
Novel Tumor Imaging Characteristics in Responders and Non-responders
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab and CMP-001 CombinationExperimental Treatment2 Interventions
Prime Phase -Nivolumab 240mg, IV Infusion, every two weeks starting with Cycle 2 ( Cycles 2, 4, 6) for 6 weeks in combination with CMP-001, 5mg, Injection, at Week 1 and the remaining injections, 10 mg will be administered Weeks 2 -7.
Boost Phase -Nivolumab 240mg, IV Infusion, every two weeks, over a 46 week period in combination with CMP-001, 5mg, administered every 4 weeks for 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMP-001
2018
Completed Phase 2
~380
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Checkmate PharmaceuticalsIndustry Sponsor
10 Previous Clinical Trials
665 Total Patients Enrolled
5 Trials studying Melanoma
329 Patients Enrolled for Melanoma
Diwakar DavarLead Sponsor
10 Previous Clinical Trials
377 Total Patients Enrolled
8 Trials studying Melanoma
321 Patients Enrolled for Melanoma
NCI (SPORE)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a disease that needs a high dose of corticosteroids every day.You have a lung disease or ongoing lung inflammation not caused by an infection.You have a disease that can be measured and treated with injections according to specific guidelines.Patients with melanoma that has spread to nearby lymph nodes or has come back in the same area after treatment.You have had melanoma in the eye or on mucous membranes.You have a history of HIV, Hepatitis B, or Hepatitis C infection.You have a condition that weakens your immune system, or you have been taking strong medication that lowers your body's ability to fight off illnesses within the last week.You have received chemotherapy, targeted small molecule therapy, or radiation therapy within the past 2 weeks and have not recovered from any side effects.You have active cancer that has spread to your brain or spinal cord.You have another type of cancer that is getting worse and needs treatment, with some exceptions.You have a current infection that needs medicine to treat it.You have already been treated with certain immunotherapy drugs.You have a confirmed diagnosis of a specific stage of skin cancer called cutaneous melanoma.You should be able to carry out all your normal activities or be up and about for at least half of your waking hours.Women who could become pregnant need to have a negative pregnancy test within a week before starting the study medication.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab and CMP-001 Combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total cohort size for this clinical research endeavor?
"Unfortunately, this clinical trial has stopped recruiting participants. Initially published on August 8th 2018 and last modified on the 24th of August 20202, this study is now closed for enrollment. However, there are currently 754 open studies related to melanoma and 718 trials utilizing Nivolumab that may be viable options for participation."
Answered by AI
Has Nivolumab been studied in any other medical investigations?
"At the present moment, there are 82 phase 3 trials and 718 active studies researching Nivolumab. Basel, BE is one of 40285 different sites where clinical tests for this drug are conducted."
Answered by AI
Is this research venture still recruiting participants?
"Clinicaltrials.gov indicates that this research project, which was first published on the 8th of August 2018 and last edited in late August 2022, is no longer looking for participants at this time. Nevertheless, there are 1,472 additional clinical trials actively recruiting patients currently."
Answered by AI
Has this kind of clinical experiment been attempted before?
"Currently, Nivolumab is the subject of 718 live trials located in 2356 cities and 49 different countries. This drug first entered clinical trial back in 2012 when Ono Pharmaceutical Co. Ltd sponsored a 659 patient study that concluded Phase 1 & 2 approval stages. Since then, an additional 254 trials have been completed successfully."
Answered by AI
Has Nivolumab been sanctioned by the Food and Drug Administration?
"Due to its status as a Phase 2 trial, which indicates that there is some data confirming the safety of Nivolumab but none so far for efficacy, we at Power assigned it a score of two."
Answered by AI
What are the primary applications of Nivolumab in medical treatment?
"Nivolumab is typically prescribed as a course of treatment for malignant tumors. Additionally, its properties are also beneficial to patients with unresectable melanoma, metastatic esophageal adenocarcinoma, and squamous cell carcinoma."
Answered by AI
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