Nivolumab for Unresectable or Metastatic Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Unresectable or Metastatic MelanomaNivolumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether two drugs, given together, are more effective than either drug given alone, for treating melanoma that has spread or can't be removed by surgery.

Eligible Conditions
  • Unresectable or Metastatic Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: baseline and before each cycle (every 4 weeks) of nivolumab for a period of 12 months

Day 30
Number of participants with treatment-related adverse events
At baseline, 12 weeks
Anti-tumor response as measured by immune-infiltration of tumor infiltrating lymphocytes
Evaluation of DNA landscape as described by total somatic mutation burden
Gene expression analysis
Month 12
Patient reported outcomes for adverse events
Month 24
Best overall response as defined by by RECIST 1.1 criteria
Immune-related Progression Free Survival (irPFS)
Immune-related overall response (irOR) defined by irRECIST
Overall survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

1 Treatment Group

Nivolumab + Talazoparib
1 of 1

Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Nivolumab + TalazoparibExperimental Group · 2 Interventions: Talazoparib, Nivolumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and before each cycle (every 4 weeks) of nivolumab for a period of 12 months

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
429 Previous Clinical Trials
30,126 Total Patients Enrolled
Pauline Funchain, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
AST (SGOT) > 3.0 X upper limit of normal.
You have a platelet count of at least 90,000/mcL.
Subjects must have histologically or cytologically confirmed diagnosis of primary or recurrent metastatic melanoma.
You have a total bilirubin of 1.5 to 3.
References

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