Advanced MelanomaPhase 2NCT04894994
FLX475 in Combination With Ipilimumab in Advanced Melanoma
A Phase 2 study testing FLX475 and Ipilimumab in people with Advanced Melanoma, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- FLX475 and Ipilimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Sep 2021to 13 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV or unresectable Stage III advanced melanoma
- Prior treatment with at least 2 months of anti-PD-(L)1 agent
- Measurable disease at baseline
- Tumor available for biopsy
Who cannot join
- History of allergy or severe hypersensitivity to biologic agents
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
- Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
Washington University School of Medicine St. Louis
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
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.
- Conditions
- Advanced Melanoma
- Being tested
- FLX475, Ipilimumab
- Keywords
- Neoplasms, Ipilimumab, Antineoplastic Agents, Immunological
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLX475Drug
Tablet
IpilimumabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| FLX475 and ipilimumab combination therapy | Experimental | Participants received FLX475 tablets orally and ipilimumab by IV infusions Receives: Drug: FLX475; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Approximately 3 weeks
Secondary outcomes (5)
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
Measured: Approximately 1 year
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
Measured: Approximately 1 year
Plasma Concentrations of FLX475
To evaluate the plasma concentrations of FLX475 when it is given in combination with ipilimumab
Measured: 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
Measured: Approximately 1 year
Tumor Control
To characterize the onset, magnitude, and duration of tumor control in subjects receiving FLX475 in combination with ipilimumab
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start3 Sep 2021
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Why it stopped: Change in clinical landscape
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Ho, MD, PhD, Study chair, RAPT Therapeutics, Inc., a member of the GSK plc group of companies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894994
- Sponsor's protocol ID
- FLX475-03
- Status last verified
- Dec 2023
- First submitted
- 12 May 2021
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT04894994
- Acronym / sponsor ID
- FLX475-03
- Conditions
- Advanced Melanoma
- Keywords
- Neoplasms, Ipilimumab, Antineoplastic Agents, Immunological
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in clinical landscape
- Enrolment
- 6 participants (actual)
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companiesIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLX475 and ipilimumab combination therapy | Experimental | Drug: FLX475, Drug: IpilimumabParticipants received FLX475 tablets orally and ipilimumab by IV infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IV or unresectable Stage III advanced melanoma
- Prior treatment with at least 2 months of anti-PD-(L)1 agent
- Measurable disease at baseline
- Tumor available for biopsy
Key exclusion criteria (3 listed)
- History of allergy or severe hypersensitivity to biologic agents
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
- Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLX475Tablet | Drug | FLX475 and ipilimumab combination therapy |
| IpilimumabIV infusion | Drug | FLX475 and ipilimumab combination therapy |
Primary outcome
Objective Response Rate
Time frame: Approximately 1 year
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
Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
Time frame: Approximately 3 weeks
Number of participants that experienced Other Adverse Events
Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events
Time frame: Approximately 3 weeks
Number of participants that experienced Serious Adverse Events
5 secondary outcomes
Progression-free Survival
Time frame: Approximately 1 year
Overall Survival (OS)
Time frame: Approximately 1 year
Plasma Concentrations of FLX475
Time frame: Approximately 1 year
Pharmacodynamic (PD) Markers
Time frame: Approximately 1 year
Tumor Control
Time frame: Approximately 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Advanced Melanoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ho, MD, PhD study chair
RAPT Therapeutics, Inc., a member of the GSK plc group of companies
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FLX475 and Ipilimumab in people with Advanced Melanoma, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Approximately 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.