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Taxane

Pembrolizumab for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Athenex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new cancer drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of MTD
Tumor response rate
Secondary outcome measures
Disease Control Rate (DCR)
Duration of response (DOR)
Incidence of Adverse Events
+4 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Dose expansion-NSCLC cancerExperimental Treatment2 Interventions
The dose expansion period will enroll subjects with NSCLC to further evaluate the activity and safety of the study treatment. Oraxol will be administered at the dose determined from part 1 for 2 out of 3 weeks. Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group II: Dose expansion-Gastric/GEExperimental Treatment2 Interventions
The dose expansion period will enroll subjects with gastric/gastro-esophageal cancer to further evaluate the activity and safety of the study treatment. Oraxol will be administered at the dose determined from part 1 for 2 out of 3 weeks. Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group III: Dose escalation-Arm 6Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 5 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group IV: Dose escalation-Arm 5Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 5 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group V: Dose escalation-Arm 4Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 5 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group VI: Dose escalation-Arm 3Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 4 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group VII: Dose escalation-Arm 2Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 3 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Group VIII: Dose escalation-Arm 1Experimental Treatment2 Interventions
During the dose escalation period Oraxol will be administered once daily for 2 days per week for 2 weeks followed by 1 week off treatment (2 weeks on and 1 week off). Pembrolizumab will be administered on Day 1 of each 3-week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Oraxol
2018
Completed Phase 3
~620

Find a Location

Who is running the clinical trial?

Athenex, Inc.Lead Sponsor
26 Previous Clinical Trials
1,934 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,519 Total Patients Enrolled
David Cutler, MDStudy DirectorSr. Vice President of Clinical Development
10 Previous Clinical Trials
641 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate on the safety of Pembrolizumab for human usage?

"Our team at Power has rated the safety of Pembrolizumab as a 1, due to it being a Phase 1 trial with limited data on both efficacy and security."

Answered by AI

Is enrollment for this trial open at the present time?

"Affirmative, the clinicaltrials.gov registry confirms that this research trial is still actively looking for participants. It was initially posted on October 25th 2018 and most recently updated on May 20th 2022 - 86 individuals are required from 3 different sites to complete enrollment."

Answered by AI

What goals are being sought after in this research endeavor?

"This clinical research aims to measure the Tumor response rate of participants over a 3-week period, as well as secondarily assess the Pharmacokinetics of Oraxol in their blood plasma, record any Adverse Events and Treatment-emergent events that occur during this time frame, and evaluate Disease Control Rate (DCR) for those studied."

Answered by AI

Does the age cutoff for this experiment exceed 30 years?

"Applicants to this research need to be adults that are 99 years old or younger."

Answered by AI

Is there an opportunity for me to join this medical experiment?

"This medical research is recruiting 86 individuals with solid tumors aged between 18 and 99. To be eligible, applicants must meet these criteria."

Answered by AI

In what situations is Pembrolizumab most efficacious?

"Pembrolizumab is an effective treatment for unresectable melanomas, high microsatellite instability cases and those with a heightened risk of recurrence."

Answered by AI

Has Pembrolizumab been a subject of any other clinical investigations?

"Pembrolizumab was first researched in 1997 at City of Hope Comprehensive Cancer Center and has since seen a total of 1375 completed trials. Currently, there are 1699 active recruitment efforts across the nation, with Jacksonville being one major site for these clinical studies."

Answered by AI

What is the maximum number of participants for this clinical trial?

"Affirmative, the clinicaltrials.gov database reflects that this trial is currently recruiting participants. It was first posted on October 25th 2018 and recently updated on May 20th 2022. So far 86 people have enrolled at 3 medical centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors
2018. "Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03588039.
~5 spots leftby Apr 2025
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