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Cytokine

Anti-PD-1 + Aldesleukin for Melanoma and Kidney Cancer

Phase 2

Recruiting

Led By Stephanie L Goff, 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

Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer

Participants must have histologically or cytologically confirmed cancer falling into one of three specified cohorts

Must not have

Concurrent systemic steroid therapy

Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose through 30 days after last treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the combination of pembrolizumab and aldesleukin to see how well it works compared to pembrolizumab alone in treating participants with metastatic or advanced melanoma or renal cell carcinoma.

Who is the study for?

Adults over 18 with advanced melanoma or renal cell carcinoma can join this trial. They must not have HIV, hepatitis B/C, be pregnant, or breastfeeding. Participants need to have finished any previous cancer treatments at least four weeks prior and agree to use birth control. They should be in good health otherwise, without severe infections or immune system problems.

What is being tested?

The trial is testing the combination of two drugs: Aldesleukin and Pembrolizumab given through IV for metastatic melanoma and renal cell carcinoma. The treatment involves hospital stays during cycles and follow-ups for up to five years including physical exams, scans, blood tests.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs used (Aldesleukin & Pembrolizumab), as well as risks associated with IV therapy such as infection at the injection site. Other common drug-related issues might involve fatigue, skin reactions, flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have melanoma or kidney cancer that can be measured for changes.

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My cancer type fits into one of the specified groups.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My organs and bone marrow work well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on steroid medication.

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I do not have any active infections, bleeding disorders, or serious illnesses that are not under control.

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I have had severe side effects from immunotherapy affecting my heart, lungs, gut, or liver.

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I have had heart surgery or symptoms due to poor blood flow.

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I have an autoimmune disease affecting a major organ.

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My lung function test shows less than or equal to 50% efficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose through 30 days after last treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose through 30 days after last treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose through 30 days after last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate in treatment refractory disease

Secondary study objectives

Progression Free Survival

Response rate in treatment naive melanoma

Safety and tolerance

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1 - Pembro and IL-2Experimental Treatment2 Interventions

Course 1: pembrolizumab (200 mg IV) on Day 1 of each cycle with aldesleukin (600,000 IU/kg intravenous bolus every eight hours) continuing for up to 4 days (maximum 10 doses) for 2 cycles (each 21 days). Course 2: pembrolizumab (200 mg IV) on Day 1 of each cycle for 2 cycles (each 21 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Aldesleukin

2012

Completed Phase 4

~1610