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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%)
Must not have
Uncontrolled opportunistic infections
Uncontrolled substantial intercurrent illness
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
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any untreated serious infections.
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I do not have any severe ongoing illnesses.
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I do not have active tuberculosis.
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I have been diagnosed with active multicentric Castleman disease.
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I have been diagnosed with primary effusion lymphoma.
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I have had symptoms of an autoimmune disease in the last 3 months.
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I have active bleeding from Kaposi's sarcoma lesions.
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I have an active hepatitis B infection.
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My Kaposi's sarcoma is severe and could threaten my life if it worsens quickly.
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I am unwilling to receive blood products even if needed for my treatment.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
safety, tolerability and activity of NHS-IL12 alone or in combination with M7824
Secondary study objectives
duration of response
objective response rates
progression free survival

Side effects data

From 2024 Phase 2 trial • 32 Patients • NCT04491955
100%
Injection site reaction
92%
Flu like symptoms
42%
Anemia
42%
Abdominal pain
42%
Aspartate aminotransferase increased
42%
Fatigue
42%
Rash acneiform
33%
Alanine aminotransferase increased
33%
Fever
33%
Pruritus
25%
Disease progression
25%
Alkaline phosphatase increased
25%
Dyspnea
25%
Urinary tract infection
17%
Back pain
17%
Dysuria
17%
Chills
17%
Constipation
17%
Proteinuria
17%
Epistaxis
17%
Hyperglycemia
17%
Nausea
17%
Pain in extremity
17%
Vomiting
8%
Hematuria
8%
Lethargy
8%
Lung infection
8%
General disorders and administration site conditions - Other, specify
8%
Cardiac troponin I increased
8%
Sepsis
8%
Adrenal insufficiency
8%
Edema face
8%
Blood bilirubin increased
8%
Cough
8%
Dry skin
8%
Gastric ulcer
8%
General disorders and administration site conditions - Other, Mucosal bleeding
8%
Hot flashes
8%
Hypokalemia
8%
Hypophosphatemia
8%
Infusion related reaction
8%
Mucositis oral
8%
Myalgia
8%
Oral hemorrhage
8%
Papulopustular rash
8%
Paresthesia
8%
Skin hyperpigmentation
8%
Thrush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2018
Completed Phase 3
~710
NHS-IL12
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,980 Total Patients Enrolled
Ramya M Ramaswami, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
598 Total Patients Enrolled

Media Library

NHS-IL12 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04303117 — Phase 1 & 2
Kaposi's Sarcoma Research Study Groups: Arm 1/Monotherapy, Arm 1a/Monotherapy Expansion, Arm 2/Combination therapy
Kaposi's Sarcoma Clinical Trial 2023: NHS-IL12 Highlights & Side Effects. Trial Name: NCT04303117 — Phase 1 & 2
NHS-IL12 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04303117 — Phase 1 & 2
~12 spots leftby Sep 2025
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