Pembrolizumab for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasms+5 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two drugs to treat previously untreated stage IV non-small cell lung cancer. The drugs are interleukin-2 and pembrolizumab.

Eligible Conditions
  • Stage IVB Lung Cancer AJCC v8
  • Malignant Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Stage IVA Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 6 months, 1 year, 3 year, and 5 years

Year 5
Overall Survival (OS)
Progression Free Survival (PFS)
Week 1
Immune Response To Combination IL-2 and Pembrolizumab
Week 6
Mutagenicity Tests
Incidence of Adverse Events (AEs)
Objective Response Rate

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab, aldesleukin)
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase < 1

Treatment (pembrolizumab, aldesleukin)Experimental Group · 2 Interventions: Aldesleukin, Pembrolizumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Pembrolizumab
2017
Completed Phase 3
~2580

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months, 1 year, 3 year, and 5 years

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,501 Previous Clinical Trials
2,677,541 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,873 Total Patients Enrolled
Suresh S Ramalingam, MD, FACP, FASCOPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have Stage IV non-small cell lung cancer (NSCLC).
You must be aged at least 18 years.\n
You have a performance status of 0-2.
You have a hemoglobin level of 9.0 g/dL or higher.
Patients must have measurable disease, as defined by RECIST 1.1 criteria.
You are symptomatic or treated and stable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 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.