Metastatic CancerPhase 2NCT05036681
A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
A Phase 2 study testing Futibatinib and Pembrolizumab in people with Metastatic Cancer and Endometrium Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
It's propose this pilot phase 2 study to explore the combination therapy of futibatinib with pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma to provide a well-tolerated regimen for durable responses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Endometrium Cancer, Endometrial Carcinoma
- What is being tested?
- Futibatinib and Pembrolizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 6 May 2025
- 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
- To be eligible for this trial, patients must meet all of the following eligibility criteria.
- Patients with histologically confirmed locally advanced or metastatic endometrial carcinoma that is not amenable to curative surgical- or radiation-based intervention, who have received or declined at least one-line systemic chemotherapy.
- Known microsatellite stable (MSS) as pre-identified in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
- At least one measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Age ≥18 years.
- Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test prior to administration of the first dose of futibatinib within 7 days prior to initiation of therapy (C1D1), and must agree to use effective birth control initiated immediately following negative serum pregnancy test during screening period, during the study, and for at least 180 days after the last dose (or longer based on local requirements). Female patients are not considered to be of child-bearing potential if they are post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
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- Adequate organ functions as defined below:
- Absolute neutrophil count (ANC) ≥ 1,000 /μL. Hemoglobin (Hb) ≥ 9 g/dL. Platelets ≥ 75,000 /μL. Total bilirubin ≤ 1.5 x ULN (upper limit of normal); or total bilirubin < 3 x ULN with direct bilirubin ≤ ULN in patients with well documented Gilbert's Syndrome.
- ALT ≤ 3 x ULN or ≤ 5 x ULN if liver metastases persist. Serum phosphate ≤ 1.5 x ULN. Serum calcium ≤ ULN. Serum albumin ≥ 3 g/dL. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 40 mL/min by the Cockcroft-Gault method or 24-hour urine collection.
- CrCl = (140-age) x (weight [kg]) x 0.85 / (72 x serum creatinine mg/dL)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- No prior treatment with anti-PD-(L)1 therapy and a FGFR inhibitor.
- Ability to read and fully understand the requirements of the trial, willingness to comply with all trial visits and assessments, and willingness and ability to sign an institutional review board (IRB)-approved written informed consent document.
- Any prior radiation must have been completed at least 14 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment (Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks).
- Ability to take oral medications without medical history of malabsorption or other chronic gastrointestinal disease, or other conditions that may hamper compliance and/or absorption of the study agents (feeding tube is not permitted).
- Provision of an archival tissue block, or 10 formalin-fixed paraffin-embedded (FFPE) slides obtained within 6 months prior to study entry; or agreeing to have biopsies if archival tissues are not available.
Who cannot join
- Patients who meet any of the following criteria will be not eligible for the study:
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association Class III or IV), history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months before study enrollment, history or current evidence of uncontrolled ventricular arrhythmia. Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death. Chronic diarrhea diseases considered to be clinically significant in the opinion of the Investigator. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or futibatinib and pembrolizumab administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- History and/or current evidence of any of the following disorders: Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator; Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator; and Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator and a trained ophthalmologist who performs the test.
- Having not recovered from a major surgical procedure or significant traumatic injury (i.e., still needing additional surgical or medical care for these issues): major surgical procedures ≤ 28 days of treatment entry, or minor surgical procedures ≤ 7 days. No waiting period required following port-a-cath or other central venous access placement.
- Unresolved clinically significant Grade 2 toxicity from prior therapy.
- Patient has an inability to swallow oral medications. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).
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- Clinically active bleeding, or active gastric or duodenal ulcer.
- Fridericia's corrected QT interval (QTcF =QT/∛(60/HR) ) > 470 ms on ECG conducted during Screening. Patients with an atrioventricular pacemaker or other condition (for example, right bundle branch block) that renders the QT measurement invalid are an exception and the criterion does not apply.
- History of allergic reactions to the study drugs, or any component of the products.
- Currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and the sponsor is required to establish eligibility.
- Any treatment specifically for systemic tumor control given within 3 weeks before the initiation of the study drugs, within 2 weeks if cytotoxic agents were given weekly, within 6 weeks for nitrosoureas or mitomycin C, within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting < 5 days, or failure to recover from toxic effects of any therapy before the initiation of the study drugs. A drug that has not received regulatory approval for any indication within 14 or 21 days of treatment for a non-myelosuppressive or myelosuppressive agent, respectively.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: Bacille Calmette-Guérin vaccine, measles, mumps, rabies, rubella, typhoid vaccine, varicella/zoster, and yellow fever. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.
- Received strong inhibitors and inducers and sensitive substrates of CYP3A4 within 2 weeks (see appendix A).
- Symptomatic primary tumors or metastasis in the brain and/or central nervous system that are uncontrolled with antiepileptics and require steroids at a dose of prednisone > 10 mg/day or equivalent.
- Evidence of leptomeningeal or lymphangitic carcinomatosis.
- A history of another primary malignancy that is currently clinically significant, requiring active intervention except for hormone therapy.
- Concurrent immunosuppressive therapy or steroid (> 10 mg/day prednisone or equivalent).
- Previously documented or suspected autoimmune disease requiring active immunosuppressive therapy (adequately treated skin rash or replacement therapy for endocrinopathies is not excluded), and history of or current pneumonitis.
- Lactation or pregnancy.
- Known human immunodeficiency virus requiring HAART treatment due to unknown drug-drug interactions or known active hepatitis B or C virus infection.
Trial locations and contacts
1 site in 1 country.
About this study
It's propose this pilot phase 2 study to explore the combination therapy of futibatinib with pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma to provide a well-tolerated regimen for durable responses.
Read the detailed description
Primary Objectives
- To evaluate the objective response rate (ORR) of futibatinib and pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma.
- To evaluate the safety and tolerability.
Primary Endpoints
- Complete responses (CRs) and partial responses (PRs) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adverse events (AEs: clinical manifestations and laboratory tests) and serious adverse events (SAEs) according to the NCI Common Terminology Criteria for Adverse Events [CTCAE] version 5.0.
- Conditions
- Metastatic Cancer, Endometrium Cancer, Endometrial Carcinoma
- Being tested
- Futibatinib, Pembrolizumab
- Medical subject headings
- Neoplasm Metastasis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FutibatinibDrug
tablets by mouth 1 time every day
PembrolizumabDrug
Given by vein over about 30-60 minutes on Day 1 of all cycles
| Study group | Role | What they receive |
|---|---|---|
| futibatini | Experimental | Not described Receives: Drug: Futibatinib |
| pembrolizumab | Experimental | Not described Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Objective Response Rate (ORR) of Futibatinib and Pembrolizumab in Patients With Metastatic Microsatellite Stable (MSS) Endometrial Carcinoma.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Progression Free Survival
Time from initiation of treatment to the occurrence of disease progression or death from any cause, whichever occurs first.
Measured: From treatment initiation until disease progression, death or last adequate disease assessment up to study termination.
Overall Survival
Time from the initiation of the treatment to death from any cause
Measured: From treatment initiation until death from any cause up to study termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start30 Sep 2021
- Primary completion30 Sep 2024
- Study completion6 May 2025
Why it stopped: PI request
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 Metastatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Siqing fu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036681
- Sponsor's protocol ID
- 2020-0776
- Other IDs
- NCI-2021-09418
- Status last verified
- Mar 2026
- First submitted
- 25 Aug 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT05036681
- Acronym / sponsor ID
- 2020-0776
- Conditions
- Metastatic Cancer, Endometrium Cancer, Endometrial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI request
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Posted 17 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It's propose this pilot phase 2 study to explore the combination therapy of futibatinib with pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma to provide a well-tolerated regimen for durable responses.
Detailed description
Primary Objectives
- To evaluate the objective response rate (ORR) of futibatinib and pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma.
- To evaluate the safety and tolerability.
Primary Endpoints
- Complete responses (CRs) and partial responses (PRs) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adverse events (AEs: clinical manifestations and laboratory tests) and serious adverse events (SAEs) according to the NCI Common Terminology Criteria for Adverse Events [CTCAE] version 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| futibatini | Experimental | Drug: Futibatinib |
| pembrolizumab | Experimental | Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- To be eligible for this trial, patients must meet all of the following eligibility criteria.
- Patients with histologically confirmed locally advanced or metastatic endometrial carcinoma that is not amenable to curative surgical- or radiation-based intervention, who have received or declined at least one-line systemic chemotherapy.
- Known microsatellite stable (MSS) as pre-identified in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
- At least one measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Age ≥18 years.
Key exclusion criteria (20 listed)
- Patients who meet any of the following criteria will be not eligible for the study:
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association Class III or IV), history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months before study enrollment, history or current evidence of uncontrolled ventricular arrhythmia. Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death. Chronic diarrhea diseases considered to be clinically significant in the opinion of the Investigator. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or futibatinib and pembrolizumab administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- History and/or current evidence of any of the following disorders: Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator; Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator; and Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator and a trained ophthalmologist who performs the test.
- Having not recovered from a major surgical procedure or significant traumatic injury (i.e., still needing additional surgical or medical care for these issues): major surgical procedures ≤ 28 days of treatment entry, or minor surgical procedures ≤ 7 days. No waiting period required following port-a-cath or other central venous access placement.
- Unresolved clinically significant Grade 2 toxicity from prior therapy.
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 |
|---|---|---|
| Futibatinibtablets by mouth 1 time every day | Drug | futibatini |
| PembrolizumabGiven by vein over about 30-60 minutes on Day 1 of all cycles | Drug | pembrolizumab |
Primary outcome
To Evaluate the Objective Response Rate (ORR) of Futibatinib and Pembrolizumab in Patients With Metastatic Microsatellite Stable (MSS) Endometrial Carcinoma.
Time frame: through study completion, an average of 1 year
2 secondary outcomes
Progression Free Survival
Time frame: From treatment initiation until disease progression, death or last adequate disease assessment up to study termination.
Overall Survival
Time frame: From treatment initiation until death from any cause up to study termination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Siqing fu principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Futibatinib and Pembrolizumab in people with Metastatic Cancer and Endometrium Cancer, run by M.D. Anderson Cancer Center at 1 site 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 16 inclusion and 20 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 17 Sep 2025). 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?
To Evaluate the Objective Response Rate (ORR) of Futibatinib and Pembrolizumab in Patients With Metastatic Microsatellite Stable (MSS) Endometrial Carcinoma. (time frame: through study completion, an average of 1 year). 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 27 Mar 2026.