Trial Outcomes & Findings for FLX475 in Combination With Ipilimumab in Advanced Melanoma (NCT NCT04894994)
NCT ID: NCT04894994
Last Updated: 2023-12-05
Results Overview
To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Approximately 1 year
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
FLX475 and Ipilimumab Combination Therapy
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FLX475 in Combination With Ipilimumab in Advanced Melanoma
Baseline characteristics by cohort
| Measure |
FLX475 and Ipilimumab Combination Therapy
n=6 Participants
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety,
To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximately 3 weeksPopulation: Participants received FLX475 tablets orally and ipilimumab by IV infusions
Number of participants that experienced Other Adverse Events
Outcome measures
| Measure |
FLX475 and Ipilimumab Combination Therapy
n=6 Participants
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
|
6 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 weeksPopulation: Participants received FLX475 tablets orally and ipilimumab by IV infusions
Number of participants that experienced Serious Adverse Events
Outcome measures
| Measure |
FLX475 and Ipilimumab Combination Therapy
n=6 Participants
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events
|
5 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety.
To evaluate the progression-free survival (PFS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: All participants who received the study drug
To evaluate the overall survival (OS) of subjects with advanced melanoma treated with FLX475 in combination with ipilimumab who have been previously treated with an anti-PD-1 or anti-PD-L1 agent
Outcome measures
| Measure |
FLX475 and Ipilimumab Combination Therapy
n=6 Participants
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Overall Survival (OS)
|
3 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety,
To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety.
To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety.
To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab
Outcome measures
Outcome data not reported
Adverse Events
FLX475 and Ipilimumab Combination Therapy
Serious events: 5 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
FLX475 and Ipilimumab Combination Therapy
n=6 participants at risk
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Investigations
Hepatic Enzyme Increased
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Hepatobiliary disorders
Hepatic Failure
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Autoimmune Colitis
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 3 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Failure to thrive
|
16.7%
1/6 • Number of events 1 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
Other adverse events
| Measure |
FLX475 and Ipilimumab Combination Therapy
n=6 participants at risk
Participants received FLX475 tablets orally and ipilimumab by IV infusions
FLX475: Tablet
Ipilimumab: IV infusion
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Autoimmune colitis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Weight decreased
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Amylase increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Hepatic enzyme increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
International normalised ratio increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Lipase increased
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
66.7%
4/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Acidosis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
3/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Autoimmune dermatitis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Nervous system disorders
Taste disorder
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Fatigue
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Pyrexia
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Chills
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Early satiety
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Hepatobiliary disorders
Hepatic failure
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Hepatobiliary disorders
Hepatic haematoma
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Campylobacter infection
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • 1 year
Adverse events were reported by the sites into an electronic data capture system
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60