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PD-1/PD-L1 Inhibitor

FLX475 for Melanoma

Phase 2
Waitlist Available
Research Sponsored by RAPT Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IV or unresectable Stage III advanced melanoma
Prior treatment with at least 2 months of anti-PD-(L)1 agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights

Study Summary

This trial is testing a new combination drug to see if it is safe and effective against advanced melanoma in patients who have already tried other treatments.

Eligible Conditions
  • Melanoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year 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
Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events
Secondary outcome measures
Overall Survival (OS)
Pharmacodynamic (PD) Markers
Plasma Concentrations of FLX475
+2 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung abscess
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: FLX475 and ipilimumab combination therapyExperimental Treatment2 Interventions
Participants received FLX475 tablets orally and ipilimumab by IV infusions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FLX475
2021
Completed Phase 2
~20
Ipilimumab
2014
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

RAPT Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
904 Total Patients Enrolled
William Ho, MD, PhDStudy ChairRAPT Therapeutics, Inc.
2 Previous Clinical Trials
394 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025