Nivolumab for Mucosal Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mucosal Melanoma+20 MoreNivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a combination of two different drugs may help patients with mucosal melanoma.

Eligible Conditions
  • Mucosal Melanoma
  • Mucosal Melanoma of the Head and Neck
  • Stage IIIC Vulvar Cancer
  • Urethral Melanoma
  • Mucosal Melanoma of the Urinary System
  • Stage IV Vulvar Cancer
  • Cervical Melanoma
  • Sinonasal Mucosal Melanoma
  • Penile Melanoma
  • Oral Cavity Mucosal Melanoma
  • Gallbladder Melanoma
  • Anal Melanoma
  • Rectal Melanoma
  • Vulvar Melanoma
  • Recurrent Mucosal Melanoma
  • Stage II Vulvar Cancer
  • Esophageal Melanoma
  • Stage IVB Vulvar Cancer
  • Vaginal Melanoma
  • Bladder Cancer
  • Stage IVA Vulvar Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS)
Year 5
RFS
Recurrence free survival (RFS)
Year 5
Progression free survival (PFS)
Year 5
Duration of response (Arm 3)
Up to 5 years
Incidence of adverse events
Overall response rate (Arm 3)

Trial Safety

Safety Progress

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

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

3 Treatment Groups

Arm 2 (nivolumab, placebo)
1 of 3
Arm 1 (nivolumab, cabozantinib)
1 of 3
Arm 3 (nivolumab, cabozantinib)
1 of 3

Active Control

Experimental Treatment

99 Total Participants · 3 Treatment Groups

Primary Treatment: Nivolumab · Has Placebo Group · Phase 2

Arm 1 (nivolumab, cabozantinib)Experimental Group · 3 Interventions: Cabozantinib S-malate, Nivolumab, Cabozantinib · Intervention Types: Drug, Biological, Drug
Arm 3 (nivolumab, cabozantinib)Experimental Group · 3 Interventions: Cabozantinib S-malate, Nivolumab, Cabozantinib · Intervention Types: Drug, Biological, Drug
Arm 2 (nivolumab, placebo)ActiveComparator Group · 2 Interventions: Placebo Administration, Nivolumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib S-malate
2013
Completed Phase 2
~470
Nivolumab
FDA approved
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,085 Previous Clinical Trials
41,141,372 Total Patients Enrolled
13 Trials studying Mucosal Melanoma
2,391 Patients Enrolled for Mucosal Melanoma
Alexander N ShoushtariPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The inclusion criteria are met.
You have a primary urethral or bladder tumor.
The patient has a primary lesion of the head and neck, or sinonasal, or LN involvement, or both.
You have a minimum vulvar- AJCC stage IIB or higher.