Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Adenocarcinoma+1 More
Trametinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Adenocarcinoma
  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3 years

Up to 2 years
Incidence of Treatment-Related Toxicity
Percentage of Participants Achieving Overall Response
Up to 3 years
Overall Survival (OS)
Up to 6 months
Recommended Phase 2 Dose (RP2D)

Trial Safety

Trial Design

3 Treatment Groups

Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation
1 of 3
Part 2: TR^2 Expansion Cohort
1 of 3
Part 1 Schedule B: TR^2 Alternate Schedule
1 of 3
Experimental Treatment

35 Total Participants · 3 Treatment Groups

Primary Treatment: Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation · No Placebo Group · Phase 1

Part 1 Schedule A: TR^2 Dose Escalation/De-EscalationExperimental Group · 3 Interventions: Trametinib, Ruxolitinib, Retifanlimab · Intervention Types: Drug, Drug, Drug
Part 2: TR^2 Expansion CohortExperimental Group · 3 Interventions: Trametinib, Ruxolitinib, Retifanlimab · Intervention Types: Drug, Drug, Drug
Part 1 Schedule B: TR^2 Alternate ScheduleExperimental Group · 3 Interventions: Trametinib, Ruxolitinib, Retifanlimab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1660
Ruxolitinib
2018
Completed Phase 3
~740
Retifanlimab
2019
Completed Phase 2
~240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: University of Miami · Miami, FL
Photo of University of Miami  1Photo of University of Miami  2Photo of University of Miami  3
1991First Recorded Clinical Trial
7 TrialsResearching Adenocarcinoma
619 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a disease or intolerance to at least one standard line of chemotherapy.
Patients who are eligible for this trial must have been treated with a PARP inhibitor before being eligible for this trial.
You have histologically confirmed, metastatic pancreatic adenocarcinoma.
You have received prior treatment with an anti-PD(L)-1 antibody.
You are a male or non-pregnant and non-lactating female.
The absolute neutrophil count (ANC) is greater than 1.0 × 10^9 cells/L.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.