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PD-1 Inhibitor
MEK/STAT3/PD-1 Inhibitors for Pancreatic Cancer
Phase 1
Recruiting
Research Sponsored by Peter Hosein, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progression of disease or intolerance to at least one standard line of chemotherapy.
Adult patients (≥ 18 years of age).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination treatment for pancreatic cancer to see if it reduces tumor size.
Who is the study for?
This trial is for adults with metastatic pancreatic ductal adenocarcinoma who've progressed after standard chemotherapy. They must have measurable tumors, be previously treated if eligible for certain drugs due to genetic mutations or high tumor mutation burden, and have good organ function and performance status. Pregnant women are excluded, as well as those with brain metastases, serious infections, heart disease, uncontrolled medical conditions or a history of severe reactions to similar drugs.Check my eligibility
What is being tested?
The study tests the effectiveness of combining three drugs: Retifanlimab (immune checkpoint inhibitor), Trametinib (MEK inhibitor), and Ruxolitinib (STAT3 inhibitor) in shrinking tumors in patients with advanced pancreatic cancer. It aims to see if this triple-drug regimen can improve outcomes compared to current treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs; skin rash; liver enzyme elevation; fatigue; gastrointestinal symptoms like nausea and diarrhea; blood count changes that could increase infection risk or cause anemia; potential heart rhythm problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened or I couldn't tolerate the chemotherapy.
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I am 18 years old or older.
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I have a BRCA1/2 mutation and have been treated with a PARP inhibitor.
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I am fully active or can carry out light work.
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I have a confirmed diagnosis of advanced pancreatic cancer, but not purely neuroendocrine cancer.
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I have a tumor that can be measured by a CT scan.
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My side effects from previous cancer treatments are mild or gone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Incidence of Treatment-Related Toxicity
Overall Survival (OS)
Percentage of Participants Achieving Overall Response
Side effects data
From 2021 Phase 2 trial • 206 Patients • NCT0203411050%
Nausea
40%
Neutropenia
30%
Diarrhoea
30%
Decreased appetite
30%
Thrombocytopenia
30%
Vomiting
30%
Anaemia
30%
Constipation
30%
Fatigue
30%
Pyrexia
30%
Rash
20%
Infection
20%
Alopecia
20%
Hypokalaemia
20%
Chills
20%
Urinary tract infection
20%
Blood alkaline phosphatase increased
20%
Spinal pain
20%
Mucosal inflammation
20%
Oedema peripheral
20%
Arthralgia
10%
Hypocalcaemia
10%
Confusional state
10%
Microcytic anaemia
10%
Dry eye
10%
Abdominal distension
10%
Dyspnoea
10%
Pain in extremity
10%
Dizziness
10%
Renal failure
10%
Influenza
10%
Cachexia
10%
Abdominal pain
10%
Pain
10%
Oropharyngeal candidiasis
10%
Radiation associated pain
10%
Hypoaesthesia
10%
Retinal detachment
10%
Cough
10%
Small intestinal obstruction
10%
Enterobacter infection
10%
Xeroderma
10%
Urinary tract infection bacterial
10%
Gastrooesophageal reflux disease
10%
Dry mouth
10%
Asthenia
10%
Gait disturbance
10%
Folliculitis
10%
Gastroenteritis
10%
Nasopharyngitis
10%
Rhinitis
10%
Sinusitis
10%
Streptococcal infection
10%
Blood creatinine increased
10%
Blood lactate dehydrogenase increased
10%
C-reactive protein increased
10%
Ejection fraction decreased
10%
Electrocardiogram QT prolonged
10%
Liver function test increased
10%
Weight decreased
10%
Back pain
10%
Bone pain
10%
Flank pain
10%
Muscular weakness
10%
Myalgia
10%
Synovial cyst
10%
Paraesthesia
10%
Depressed mood
10%
Insomnia
10%
Benign prostatic hyperplasia
10%
Lung disorder
10%
Skin mass
10%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Multiple Myeloma (MM) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Biliary Tract Cancer (BTC) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 2: TR^2 Expansion CohortExperimental Treatment3 Interventions
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.
Group II: Part 1 Schedule B: TR^2 Alternate ScheduleExperimental Treatment3 Interventions
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.
Group III: Part 1 Schedule A: TR^2 Dose Escalation/De-EscalationExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Retifanlimab
Not yet FDA approved
Ruxolitinib
FDA approved
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,856 Previous Clinical Trials
4,197,670 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,130 Total Patients Enrolled
Peter Hosein, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened or I couldn't tolerate the chemotherapy.I have had interstitial lung disease or pneumonitis.I have not received a live vaccine in the last 30 days.I do not have any serious health or mental conditions that could affect my safety or the study's results.I am not currently participating in any other cancer drug trials.I am willing and able to follow the study's procedures.My cancer has spread to my brain.I am unable to make my own medical decisions.I have fluid buildup in my abdomen that isn't managed.I have a neuroendocrine tumor in my pancreas.My ability to care for myself has worsened since my last doctor's visit.I understand the study details and have signed the consent form.I do not have uncontrolled heart problems.I am 18 years old or older.I am a man or a woman not currently pregnant or breastfeeding, and I agree to use contraception.I do not have any stomach or bowel problems that could affect how I absorb medication.I have a BRCA1/2 mutation and have been treated with a PARP inhibitor.I have a history of liver disease.I am fully active or can carry out light work.I do not have any ongoing serious infections requiring treatment.I have a history of HIV or Hepatitis B/C.I haven't taken high doses of steroids like prednisone (10 mg or more daily) in the last two weeks.I have a confirmed diagnosis of advanced pancreatic cancer, but not purely neuroendocrine cancer.I have a tumor that can be measured by a CT scan.I have been treated with an anti-PD-1 antibody for my high MSI or TMB cancer.My side effects from previous cancer treatments are mild or gone.I am not allergic to the study drugs or similar medications.It's been over two weeks since my last cancer treatment.I am not taking any substances that can't be stopped a week before starting the treatment.My high blood pressure is not controlled by medication.I am up to date with all FDA-approved COVID-19 vaccinations.I have a history or risk of eye blood vessel blockage or swelling.You have a history of an autoimmune disease that could get worse if you take a certain kind of medication called an immune checkpoint inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation
- Group 2: Part 2: TR^2 Expansion Cohort
- Group 3: Part 1 Schedule B: TR^2 Alternate Schedule
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for people to join this research project?
"It appears that this trial is no longer actively seeking applicants, given the most recent update on November 2nd 2022. Despite its closure for enrollment, 802 other medical trials are still open to recruitment as of today."
Answered by AI
Has the FDA rendered a verdict on Trametinib's safety?
"Exploratory research has been done on trametinib, so it is allocated a score of 1 to indicate its low level of safety and efficacy."
Answered by AI
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