Pancreatic Ductal AdenocarcinomaPhase 1NCT05440942
Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing Trametinib, Ruxolitinib and Retifanlimab in people with Pancreatic Ductal Adenocarcinoma, run by Peter Hosein, MD at 1 site in United States.
Trial summary
The purpose of this research is to test whether a combination treatment of Trametinib, Retifanlimab, and Ruxolitinib (TR^2) will reduce tumor size in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Trametinib, Ruxolitinib and Retifanlimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 30 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed, metastatic pancreatic adenocarcinoma. Patients with adenosquamous carcinoma and mixed adenocarcinoma/neuroendocrine carcinoma (MANEC) of the pancreas are eligible, but pure neuroendocrine neoplasms are excluded.
- Progression of disease or intolerance to at least one standard line of chemotherapy.
- Patients who are candidate for an anti-PD-1 antibody due to Microsatellite instability -High (MSI-H) or tumor mutational burden (TMB)-high status must have been treated with this drug before being eligible for this trial.
- Prior treatment with an anti-PD(L)-1 antibody is allowed unless this therapy was stopped due to an immune-related adverse event.
- Patients who are candidate for a poly (ADP-ribose) polymerase (PARP) inhibitor due to a germline BRCA1/2 mutation must have been treated with this drug before being eligible for this trial.
- At least one tumor measurable by CT scan. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or >10 mm with spiral CT scan.
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- Adult patients (≥ 18 years of age).
- Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception as outlined in Section 4.9.
- Adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
- Absolute neutrophil count (ANC) ≥ 1.0 × 10^9 cells/L.
- Platelet count ≥ 100,000 cells/mm3 (100 × 10^9 cells/L).
- Hemoglobin (Hgb) ≥ 9 g/dL.
- Adequate blood chemistry levels at Screening (obtained ≤ 21 days prior to enrollment) and at Baseline-Day 0:
- Aspartate aminotransferase (AST) - serum glutamic-oxaloacetic transaminase (SGOT); alanine transaminase (ALT) - serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 × upper limit of normal (ULN) range, unless liver metastases are present, then ≤ 5 × ULN is allowed.
- Total bilirubin ≤ 1.5 × ULN.
- Estimated creatinine clearance of > 60 mL/min (per Cockcroft-Gault formula).
- Albumin ≥ 3.0 g/dL.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to ≤ 1 (see APPENDIX A: PERFORMANCE STATUS SCALES).
- At least two weeks since the last anti-cancer therapy (e.g., chemotherapy, radiation therapy).
- All toxicities from the last anti-cancer therapy should be resolved to < grade 1.
- Patient has been informed about the nature of the study, has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Who cannot join
- Patients with pure neuroendocrine neoplasms of the pancreas.
- Brain metastases.
- Uncontrolled ascites.
- Increase of ECOG to > 1 between screening and enrollment.
- Corrected QT interval (QTcF) > 450 msec.
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
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- History of HIV and/or Hepatitis B or C infection.
- History of active autoimmune disease that, in the opinion of the Investigator, could deteriorate upon treatment with an immune checkpoint inhibitor.
- Concurrent use of systemic corticosteroids equivalent to or greater than prednisone 10 mg/day within two weeks of start of study therapy.
- Receipt of a live vaccine within 30 days prior to enrollment.
- Patients who are not up to date on FDA-approved coronavirus disease 2019 (COVID-19) vaccination series will be excluded.
- Any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection).
- History of interstitial lung disease or pneumonitis.
- History of liver disease as follows:
- Cirrhosis
- Autoimmune hepatitis
- Portal hypertension
- Drug-induced liver steatosis
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
- History of myocardial infarction, angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to study entry
- Documented cardiomyopathy
- Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome or any of the following risk factors for Torsades de Pointe, including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
- Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within five half-lives or seven days prior to starting study drug).
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade arterioventricular block (e.g., bifascicular block, Mobitz type II, and third-degree atrioventricular block).
- Treatment refractory hypertension defined as a blood pressure of systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) > 90 mm Hg that cannot be controlled by anti-hypertensive therapy.
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) including:
- Presence of predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or a history of hyperviscosity or hypercoagulability syndromes); or
- Visible retinal pathology as assessed by ophthalmic examination that is considered a risk factor for RVO or CSR.
- Currently receiving any of the following substances and cannot be discontinued seven days prior to Cycle 1 Day 1:
- Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges.
- Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Herbal preparations/medications and/or dietary supplements.
- History of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class, or any of their excipients.
- Concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or integrity of the study data.
- Concurrently enrolled in any other interventional clinical protocol or investigational trial involving administration of antineoplastic compounds for the treatment of metastatic pancreatic cancer.
- Patient is unwilling or unable to comply with study procedures.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Trial of Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this research is to test whether a combination treatment of Trametinib, Retifanlimab, and Ruxolitinib (TR^2) will reduce tumor size in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Read the detailed description
Adenocarcinoma of the pancreas (PDAC) remains a major therapeutic challenge due to its innate and acquired chemoresistance. Three major contributors to therapeutic resistance that have been difficult to overcome in PDAC are mutations in the KRAS oncogene, the presence of a dense desmoplastic stroma that acts as a barrier to drug delivery and effector immune cell infiltration, and the immunosuppressive tumor microenvironment (TME) that renders the tumor innately resistant to immunotherapy.
The Merchant and Datta labs at the University of Miami (UM) has extensively studied the targeting of downstream effectors of oncogenic RAS. They have shown that mitogen-activated extracellular signal-regulated kinase inhibition (MEKi) results in reciprocal activation of signal transducer and activator of transcription 3 (STAT3) signaling, which confers therapeutic resistance and continued PDAC cell growth. Combined inhibition of Janus kinases (JAK)/STAT3 (STAT3i) and MEKi overcomes therapeutic resistance following RAS inhibition that is mediated through parallel feedback loop activation.
They have also identified a novel mechanism showing that combined MEKi and STAT3i also inhibits tumor fibrosis and enhances CD8+ cytotoxic T-cell (CTL) infiltration to the tumor while downregulating immunosuppressive regulatory T cells (Tregs) and myeloid derived suppressor cells (MDSCs) in the TME, resulting in reduced tumor burden and improved survival in genetically engineered mouse models of PDAC.
Furthermore, they have shown that the anti-tumor effects of MEKi and STAT3i are T-cell dependent. This change in the TME, however, is accompanied by sustained PD-L1/PD-1 and cytotoxic T lymphocyte antigen-4 (CTLA-4) expression. The preliminary results further demonstrate that combined MEKi and STAT3i with PD-1 inhibition can harness the effects of immune checkpoint inhibitors for an enhanced anti-tumor response.
Based on many years of preclinical investigation, this triplet combination appears to be a promising option and this clinical trial will tests its safety and effectiveness in patients with metastatic PDAC.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Trametinib, Ruxolitinib, Retifanlimab
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrametinibDrug
Also called GSK1120212, TMT212-NXA, Mekinist
Trametinib will be administered orally once daily via tablet.
RuxolitinibDrug
Also called INCB018424, INC424
Ruxolitinib will be administered orally twice daily (BID) via tablet.
RetifanlimabDrug
Also called INCMGA00012
Retifanlimab will be administered intravenously (IV) on Day 8 of a 28-day cycle..
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation | Experimental | Participants in this group will receive Trametinib, Ruxolitinib and Retifanlimab in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive Trametinib and Ruxolitinib for two weeks on (Days 1-14) and two weeks off (Days 15-28) and Retifanlimab on Day 8 of a 28-day cycle. Doses will be administered as follows:
* Dose Level -1A: Trametinib 1 mg orally (PO), Ruxolitinib 5 mg PO, Retifanlimab 500 mg intravenously (IV);
* Starting Dose Level 1A: Trametinib 1.5 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV;
* Dose Level 2A: Trametinib 2 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV;
* Dose Level 3A: Trametinib 2 mg PO, Ruxolitinib 15 mg PO, Retifanlimab 500 mg IV. Receives: Drug: Trametinib; Drug: Ruxolitinib; Drug: Retifanlimab |
| Part 1 Schedule B: TR^2 Alternate Schedule | Experimental | Participants in this group will receive the MTD determined in Part 1 Schedule A on a continuous dosing cycle: Trametinib and Ruxolitinib on Days 1-28 and Retifanlimab on Day 8 of a 28-Day Cycle. Receives: Drug: Trametinib; Drug: Ruxolitinib; Drug: Retifanlimab |
| Part 2: TR^2 Expansion Cohort | Experimental | Participants in this group will receive Trametinib, Ruxolitinib and Retifanlimab at the most appropriate dose and schedule determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression. Receives: Drug: Trametinib; Drug: Ruxolitinib; Drug: Retifanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
The RP2D of combination therapy of trametinib, ruxolitinib and retifanlimab (TR^2) therapy will be determined as the maximum tolerated dose of combination treatment (in mg) as assessed by treating physician using the NCI-CTCAE Version 5.0.
Measured: Up to 6 months
Secondary outcomes (3)
Incidence of Treatment-Related Toxicity
The incidence of treatment-related dose limiting toxicities (DLTs), serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) in study participants receiving combination TR^2 therapy will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 2 years
Overall Survival (OS)
Overall survival (OS) is defined as the elapsed time from study treatment initiation to death or date of censoring. Participants alive or those lost to follow-up will be censored at the last date known to be alive. OS rate will be reported as the percentage of participants still alive after start of treatment.
Measured: Up to 3 years
Percentage of Participants Achieving Overall Response
Overall response will be determined as the percentage of participants achieving complete response (CR) or partial response to combination TR^2 treatment. Response will be assessed by treating physician using the revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start19 Jan 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose escalation/de-escalation and dose expansion design.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Hosein, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation, Novartis Pharmaceuticals, University of Miami Sylvester Comprehensive Cancer Center
- Responsible party
- Sponsor-investigator, Peter Hosein, MD, University of Miami
- Investigators
- Peter Hosein, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440942
- Sponsor's protocol ID
- 20220171
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05440942
- Acronym / sponsor ID
- 20220171
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Peter Hosein, MDUniversity, hospital or other
- Collaborators
- Incyte Corporation, Novartis Pharmaceuticals, University of Miami Sylvester Comprehensive Cancer Center
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test whether a combination treatment of Trametinib, Retifanlimab, and Ruxolitinib (TR^2) will reduce tumor size in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Detailed description
Adenocarcinoma of the pancreas (PDAC) remains a major therapeutic challenge due to its innate and acquired chemoresistance. Three major contributors to therapeutic resistance that have been difficult to overcome in PDAC are mutations in the KRAS oncogene, the presence of a dense desmoplastic stroma that acts as a barrier to drug delivery and effector immune cell infiltration, and the immunosuppressive tumor microenvironment (TME) that renders the tumor innately resistant to immunotherapy.
The Merchant and Datta labs at the University of Miami (UM) has extensively studied the targeting of downstream effectors of oncogenic RAS. They have shown that mitogen-activated extracellular signal-regulated kinase inhibition (MEKi) results in reciprocal activation of signal transducer and activator of transcription 3 (STAT3) signaling, which confers therapeutic resistance and continued PDAC cell growth. Combined inhibition of Janus kinases (JAK)/STAT3 (STAT3i) and MEKi overcomes therapeutic resistance following RAS inhibition that is mediated through parallel feedback loop activation.
They have also identified a novel mechanism showing that combined MEKi and STAT3i also inhibits tumor fibrosis and enhances CD8+ cytotoxic T-cell (CTL) infiltration to the tumor while downregulating immunosuppressive regulatory T cells (Tregs) and myeloid derived suppressor cells (MDSCs) in the TME, resulting in reduced tumor burden and improved survival in genetically engineered mouse models of PDAC.
Furthermore, they have shown that the anti-tumor effects of MEKi and STAT3i are T-cell dependent. This change in the TME, however, is accompanied by sustained PD-L1/PD-1 and cytotoxic T lymphocyte antigen-4 (CTLA-4) expression. The preliminary results further demonstrate that combined MEKi and STAT3i with PD-1 inhibition can harness the effects of immune checkpoint inhibitors for an enhanced anti-tumor response.
Based on many years of preclinical investigation, this triplet combination appears to be a promising option and this clinical trial will tests its safety and effectiveness in patients with metastatic PDAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1 dose escalation/de-escalation and dose expansion design.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation | Experimental | Drug: Trametinib, Drug: Ruxolitinib, Drug: RetifanlimabParticipants in this group will receive Trametinib, Ruxolitinib and Retifanlimab in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive Trametinib and Ruxolitinib for two weeks on (Days 1-14) and two weeks off (Days 15-28) and Retifanlimab on Day 8 of a 28-day cycle. Doses will be administered as follows: * Dose Level -1A: Trametinib 1 mg orally (PO), Ruxolitinib 5 mg PO, Retifanlimab 500 mg intravenously (IV); * Starting Dose Level 1A: Trametinib 1.5 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV; * Dose Level 2A: Trametinib 2 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV; * Dose Level 3A: Trametinib 2 mg PO, Ruxolitinib 15 mg PO, Retifanlimab 500 mg IV. |
| Part 1 Schedule B: TR^2 Alternate Schedule | Experimental | Drug: Trametinib, Drug: Ruxolitinib, Drug: RetifanlimabParticipants in this group will receive the MTD determined in Part 1 Schedule A on a continuous dosing cycle: Trametinib and Ruxolitinib on Days 1-28 and Retifanlimab on Day 8 of a 28-Day Cycle. |
| Part 2: TR^2 Expansion Cohort | Experimental | Drug: Trametinib, Drug: Ruxolitinib, Drug: RetifanlimabParticipants in this group will receive Trametinib, Ruxolitinib and Retifanlimab at the most appropriate dose and schedule determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed, metastatic pancreatic adenocarcinoma. Patients with adenosquamous carcinoma and mixed adenocarcinoma/neuroendocrine carcinoma (MANEC) of the pancreas are eligible, but pure neuroendocrine neoplasms are excluded.
- Progression of disease or intolerance to at least one standard line of chemotherapy.
- At least one tumor measurable by CT scan. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or >10 mm with spiral CT scan.
- Adult patients (≥ 18 years of age).
- Male or non-pregnant and non-lactating female. Men and women with intact reproductive potential must agree to use contraception as outlined in Section 4.9.
Key exclusion criteria (38 listed)
- Patients with pure neuroendocrine neoplasms of the pancreas.
- Brain metastases.
- Uncontrolled ascites.
- Increase of ECOG to > 1 between screening and enrollment.
- Corrected QT interval (QTcF) > 450 msec.
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 |
|---|---|---|
| TrametinibAlso: GSK1120212, TMT212-NXA, MekinistTrametinib will be administered orally once daily via tablet. | Drug | Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation, Part 1 Schedule B: TR^2 Alternate Schedule, Part 2: TR^2 Expansion Cohort |
| RuxolitinibAlso: INCB018424, INC424Ruxolitinib will be administered orally twice daily (BID) via tablet. | Drug | Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation, Part 1 Schedule B: TR^2 Alternate Schedule, Part 2: TR^2 Expansion Cohort |
| RetifanlimabAlso: INCMGA00012Retifanlimab will be administered intravenously (IV) on Day 8 of a 28-day cycle.. | Drug | Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation, Part 1 Schedule B: TR^2 Alternate Schedule, Part 2: TR^2 Expansion Cohort |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 6 months
The RP2D of combination therapy of trametinib, ruxolitinib and retifanlimab (TR^2) therapy will be determined as the maximum tolerated dose of combination treatment (in mg) as assessed by treating physician using the NCI-CTCAE Version 5.0.
3 secondary outcomes
Incidence of Treatment-Related Toxicity
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 3 years
Percentage of Participants Achieving Overall Response
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Laboratory evidence that led to the development of this clinical trial (currently under peer review)Link 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.
Peter Hosein, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trametinib, Ruxolitinib and Retifanlimab in people with Pancreatic Ductal Adenocarcinoma, run by Peter Hosein, MD 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 21 inclusion and 38 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: finished, as of the sponsor's last update on 5 Jun 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recommended Phase 2 Dose (RP2D) (time frame: Up to 6 months). 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 Jun 2025.