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Cytokine
NHS-IL12 + M7824 for Kaposi Sarcoma
Phase 1 & 2
Recruiting
Led By Ramya M Ramaswami, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resolution of toxicity from prior therapy to less than or equal to Grade 1
ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
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.
Who is the study for?
Adults over 18 with Kaposi Sarcoma (KS) who've had prior treatments that didn't work well can join. This includes those living with HIV, provided they meet certain viral load and immune cell count criteria. Participants need measurable KS lesions and good organ/marrow function. They must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing NHS-IL12 alone or combined with M7824 in treating KS. NHS-IL12 boosts the immune system against tumors, while M7824 blocks cancer pathways that inhibit the immune response. The drugs are given via injections under the skin or through a vein for up to 96 weeks.See study design
What are the potential side effects?
Potential side effects of NHS-IL12 and M7824 include reactions at injection sites, flu-like symptoms, fatigue, changes in blood tests affecting organs like liver/kidneys/blood cells, allergic reactions similar to other compounds in these drugs' families.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments are mild.
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I can take care of myself but might not be able to do active work.
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I have Kaposi sarcoma confirmed by a lab and need treatment that affects my whole body.
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I have been on HIV treatment for 8+ weeks and meet specific viral load and CD4 count criteria.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
safety, tolerability and activity of NHS-IL12 alone or in combination with M7824
Secondary outcome measures
duration of response
objective response rates
progression free survival
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 2/Combination therapyExperimental Treatment2 Interventions
Treatment with NHS-IL12 at MTD and M7824 at a fixed dose
Group II: Arm 1a/Monotherapy ExpansionExperimental Treatment1 Intervention
Treatment with NHS-IL12 at MTD
Group III: Arm 1/MonotherapyExperimental Treatment1 Intervention
Treatment with NHS-IL12 at de-escalating doses if necessary
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
M7824
2020
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,790 Total Patients Enrolled
Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
489 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any untreated serious infections.You have a specific type of measurable disease according to the AIDS Clinical Trials Group (ACTG) Oncology Committee criteria for KS.My organs and bone marrow are functioning well.I have been diagnosed with active multicentric Castleman disease.I have not had chemotherapy in the last 2 weeks or immunotherapy in the last 4 weeks.My side effects from previous treatments are mild.You can participate whether you have HIV or not.I have had cancer other than Kaposi's sarcoma, but under certain conditions.I have not received a live vaccine within 30 days before starting the study treatment.I do not have any severe ongoing illnesses.I do not have active tuberculosis.I have been diagnosed with primary effusion lymphoma.I have Kaposi's sarcoma and treatments I've tried didn't work well.I can take care of myself but might not be able to do active work.You have uncontrolled hepatitis C virus (HCV) infection, which means that the virus can be detected in your blood.I have Kaposi sarcoma confirmed by a lab and need treatment that affects my whole body.I have had symptoms of an autoimmune disease in the last 3 months.I agree to use birth control during the study due to unknown effects on fetuses.I have been on HIV treatment for 8+ weeks and meet specific viral load and CD4 count criteria.I am aware I may not qualify for the combination therapy due to certain conditions.I have active bleeding from Kaposi's sarcoma lesions.I am 18 years old or older.I have an active hepatitis B infection.You have had allergic reactions to similar drugs to the ones being studied.My Kaposi's sarcoma is severe and could threaten my life if it worsens quickly.I am unwilling to receive blood products even if needed for my treatment.I have at least 5 skin lesions from Kaposi's sarcoma that haven't been treated locally.You have had significant bleeding or clotting issues in the past 4 weeks that could make it risky to take the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1/Monotherapy
- Group 2: Arm 1a/Monotherapy Expansion
- Group 3: Arm 2/Combination therapy
Awards:
This trial has 1 awards, including:- 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.
Is there an ongoing recruitment process for this clinical experiment?
"Affirmative. Clinicaltrials.gov conveys that this clinical trial is currently soliciting patients, with the initial posting taking place on July 13th 2020 and a subsequent edit made October 14th 2022. 64 persons must be recruited from 1 medical centre for the study to reach completion."
Answered by AI
How many participants have committed to this research endeavor?
"Affirmative. Evidenced by the records on clinicaltrials.gov, this medical study is currently enrolling subjects. The investigation was first published on July 13th 2020 and its details were lastly modified on October 14th 2022. A total of 64 patients are required at one site for completion of the trial."
Answered by AI
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