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Checkpoint Inhibitor

Talazoparib + Nivolumab for Melanoma

Phase 2
Waitlist Available
Led By James Isaacs, MD
Research Sponsored by Case Comprehensive Cancer Center
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 baseline and before each cycle (every 4 weeks) of nivolumab for a period of 12 months
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and before each cycle (every 4 weeks) of nivolumab for a period of 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and before each cycle (every 4 weeks) of nivolumab for a period of 12 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
Best overall response as defined by by RECIST 1.1 criteria
Secondary outcome measures
Immune-related Progression Free Survival (irPFS)
Immune-related overall response (irOR) defined by irRECIST
Number of participants with treatment-related adverse events
+2 more
Other outcome measures
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
+1 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%
Rash
14%
Hyponatraemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Neoplasm progression
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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 + TalazoparibExperimental Treatment2 Interventions
Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,902 Total Patients Enrolled
12 Trials studying Melanoma
431 Patients Enrolled for Melanoma
James Isaacs, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Melanoma
12 Patients Enrolled for Melanoma
Pauline Funchain, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04187833 — Phase 2
Melanoma Research Study Groups: Nivolumab + Talazoparib
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04187833 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04187833 — Phase 2

Frequently Asked Questions

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

Are we able to sign people up for this research project at this time?

"This clinical trial, which was originally posted on 6/5/2020 and had its most recent update on 3/22/2022, is currently looking for patients that match the given criteria."

Answered by AI

What is the medical community's experience with Nivolumab thus far?

"At present time, there are 804 live studies for Nivolumab with 85 trials in Phase 3. While several of the studies for Nivolumab are based in Duarte, California, there are 42563 locations operating trials for Nivolumab globally."

Answered by AI

Is Nivolumab likely to cause any adverse health effects?

"Nivolumab's safety was rated a 2 because, while there is some data supporting its safety profile, none of it suggests that the medication is effective."

Answered by AI

What illnesses has Nivolumab been proven to fight against?

"Nivolumab is an immunotherapy medication that can help fight cancerous growths. It has been shown to be effective in treating unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Could you help me understand how many people are included in this clinical trial?

"That is correct. The clinical trial mentioned is actively recruiting patients, with the most recent update being on March 22nd, 2022. Only 37 participants are needed for the study, which will be conducted at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes
2020. "Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04187833.
~2 spots leftby Apr 2025
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