NHS-IL12 for Kaposi Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaposi Sarcoma+2 More
NHS-IL12 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for people with Kaposi sarcoma who have received chemotherapy or immunotherapy in the past. The trial will test the effects of two non-chemotherapy drugs, NHS-IL12 and M7824, given alone or in combination, to see if they can help the immune system fight KS tumors.

Eligible Conditions
  • Kaposi Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: every 3 months for the first 6 months after completion of therapy, then every six months for the next 18 months, and then annually for a total of 3 years

24 cycles of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal
safety and tolerability of NHS-IL12 alone or in combination with M7824
safety, tolerability and activity of NHS-IL12 alone or in combination with M7824
Year 3
duration of response
objective response rates
progression free survival

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Arm 1a/Monotherapy Expansion
1 of 3
Arm 1/Monotherapy
1 of 3
Arm 2/Combination therapy
1 of 3

Experimental Treatment

64 Total Participants · 3 Treatment Groups

Primary Treatment: NHS-IL12 · No Placebo Group · Phase 1 & 2

Arm 1a/Monotherapy Expansion
Drug
Experimental Group · 1 Intervention: NHS-IL12 · Intervention Types: Drug
Arm 1/Monotherapy
Drug
Experimental Group · 1 Intervention: NHS-IL12 · Intervention Types: Drug
Arm 2/Combination therapyExperimental Group · 3 Interventions: NHS-IL12+M7824, M7824, NHS-IL12 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M7824
2019
Completed Phase 2
~240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 3 months for the first 6 months after completion of therapy, then every six months for the next 18 months, and then annually for a total of 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,995 Previous Clinical Trials
41,299,872 Total Patients Enrolled
Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
317 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have biopsy proven (confirmed in the Laboratory of Pathology, CCR) Kaposi sarcoma (KS).
T1 or T0 KS affecting quality-of-life due to local symptoms or psychological distress.
You have had prior therapy to less than or equal to Grade 1.
You are HIV positive or negative.
Patients must be younger than or equal to 18 years of age.
At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.
You have measurable disease by the criteria proposed by the AIDS Clinical Trials Group (ACTG) Oncology Committee for KS.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 16th, 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.