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Change in clinical landscape
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This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.
The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLX475 and ipilimumab combination therapy | Experimental | Participants received FLX475 tablets orally and ipilimumab by IV infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLX475 | Drug | Tablet |
| |
| Ipilimumab |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 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 | Approximately 1 year |
| Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events | Number of participants that experienced Other Adverse Events | Approximately 3 weeks |
| Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events | Number of participants that experienced Serious Adverse Events | Approximately 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 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 | Approximately 1 year |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Ho, MD, PhD | RAPT Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Moffitt Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | FLX475 and Ipilimumab Combination Therapy | Participants received FLX475 tablets orally and ipilimumab by IV infusions FLX475: Tablet Ipilimumab: IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FLX475 and Ipilimumab Combination Therapy | Participants received FLX475 tablets orally and ipilimumab by IV infusions FLX475: Tablet Ipilimumab: IV infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate | 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 | This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety, | Posted | Approximately 1 year |
|
|
1 year
Adverse events were reported by the sites into an electronic data capture system
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FLX475 and Ipilimumab Combination Therapy | Participants received FLX475 tablets orally and ipilimumab by IV infusions FLX475: Tablet Ipilimumab: IV infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic Enzyme Increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
The study was terminated early due to changes in the treatment landscape of melanoma that have occurred since the initiation of the study, leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Ho | RAPT Therapeutics | 650-489-9037 | bill.ho@RAPT.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2020 | Sep 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2022 | Sep 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
IV infusion |
|
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 |
| Approximately 1 year |
| Plasma Concentrations of FLX475 | To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab | Approximately 1 year |
| Pharmacodynamic (PD) Markers | To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action | Approximately 1 year |
| Tumor Control | To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab | Approximately 1 year |
| Tampa |
| Florida |
| 33612 |
| United States |
| Washington University School of Medicine St. Louis | St Louis | Missouri | 63110 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| Primary | Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events | Number of participants that experienced Other Adverse Events | Participants received FLX475 tablets orally and ipilimumab by IV infusions | Posted | Count of Participants | Participants | Approximately 3 weeks |
|
|
|
| Secondary | Progression-free Survival | 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 | This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety. | Posted | Approximately 1 year |
|
|
| Secondary | Overall Survival (OS) | 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 | All participants who received the study drug | Posted | Count of Participants | Participants | Approximately 1 year |
|
|
|
| Secondary | Plasma Concentrations of FLX475 | To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab | This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety, | Posted | Approximately 1 year |
|
|
| Secondary | Pharmacodynamic (PD) Markers | To assess the effects of FLX475 in combination with ipilimumab on pharmacodynamic (PD) markers relating to drug mechanism of action | This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety. | Posted | Approximately 1 year |
|
|
| Secondary | Tumor Control | To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab | This outcome was not measured as the study was prematurely terminated for reasons unrelated to safety. | Posted | Approximately 1 year |
|
|
| Primary | Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events | Number of participants that experienced Serious Adverse Events | Participants received FLX475 tablets orally and ipilimumab by IV infusions | Posted | Count of Participants | Participants | Approximately 3 weeks |
|
|
|
| 3 |
| 6 |
| 5 |
| 6 |
| 6 |
| 6 |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Autoimmune Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Autoimmune colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Autoimmune dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic haematoma | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Campylobacter infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |