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Monoclonal Antibodies

APX005M + Nivolumab + Ipilimumab for Melanoma

Phase 1

Waitlist Available

Led By Harriet Kluger, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior focal radiotherapy is allowed. Radiation to pulmonary or intestinal sites must be completed at least 1 week prior to study Day 1. Radiation to the brain must be completed within 4 weeks prior to initiation of treatment. There is no time restriction prior to study Day 1 for patients who have received radiation to bone, soft tissue or other sites. No radiopharmaceuticals (strontium, samarium) within 8 weeks before first dose of study drug administration.

ECOG performance status < 2

Must not have

Active (non-infectious) pneumonitis.

Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) acute or chronic infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, APX005M, to see if it is safe and effective when used with nivolumab and ipilimumab to treat advanced melanoma and renal cell carcinoma.

Who is the study for?

Adults with advanced melanoma or RCC, who haven't had systemic immune therapy for their condition. They must be in good health, have a life expectancy of at least 6 months, and agree to use effective contraception. Those with stable brain metastases may qualify; however, individuals with certain heart conditions, active infections requiring IV antibiotics, or recent participation in other clinical trials are excluded.

What is being tested?

The trial is testing the combination of APX005M with Nivolumab and Ipilimumab to see how safe and effective it is against advanced melanoma and RCC. It's an early-phase study where doses will be adjusted to find the right balance between efficacy and tolerability.

What are the potential side effects?

Potential side effects include typical reactions associated with immunotherapy such as fatigue, skin reactions, digestive issues like diarrhea or colitis, liver inflammation (hepatitis), hormonal gland problems (like thyroid disorders), lung inflammation (pneumonitis), infusion-related reactions and possibly others.

Eligibility Criteria

Inclusion Criteria

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

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I've had radiation therapy but not with radiopharmaceuticals in the last 8 weeks.

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I can do most of my daily activities without help.

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I am willing to have a tumor biopsy before and during the treatment.

Exclusion Criteria

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

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I have lung inflammation that is not caused by an infection.

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I have HIV, HBV, or HCV infection.

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I've had severe nerve, heart, or liver side effects from previous cancer immunotherapy.

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I have not had a heart attack or unstable chest pain in the last 3 months.

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I have brain metastases that have not been treated.

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I am not currently in any other clinical trials or have been in one within the last 4 weeks.

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My cancer has spread to the lining of my brain and spinal cord.

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I do not have any open wounds or active skin infections.

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I have an autoimmune disease treated with strong medication in the last year.

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I do not have any other active cancers besides the one being studied, except for skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Dose-limiting toxicities

Recommended dose of APX005M

Secondary study objectives

Adverse Events Frequency

Adverse Events Rate

Side effects data

From 2020 Phase 1 & 2 trial • 140 Patients • NCT03123783

50%

Pyrexia

50%

Nausea

43%

Dyspnoea

36%

Fatigue

36%

Chills

29%

Asthenia

29%

Alanine aminotransferase increased

29%

Gamma-glutamyltransferase increased

29%

Decreased appetite

29%

Pruritus

29%

Aspartate aminotransferase increased

21%

Malaise

21%

Oedema peripheral

21%

Abdominal pain upper

21%

Constipation

21%

Arthralgia

21%

Cough

14%

Chest discomfort

14%

Upper respiratory tract infection

14%

Infusion related reaction

14%

Blood alkaline phosphatase

14%

Pneumonia

14%

Abdominal pain

14%

Diarrhoea

14%

Dry mouth

14%

Vomiting

14%

Musculoskeletal pain

14%

Headache

14%

Somnolence

14%

Upper-airway cough syndrome

14%

Hyperhidrosis

Vocal cord paralysis

Tremor

Deep vein thrombosis

Dysgeusia

Blood alkaline phosphatase increased

Cardiac arrest

Pericardial effusion

Blood creatinine increased

Cancer pain

Brain oedema

Encephalitis autoimmune

Chronic obstructive pulmonary disease

Pulmonary embolism

Tachycardia

Hypothyroidism

Vision blurred

Weight decreased

Back pain

Musculoskeletal chest pain

Myalgia

Neck pain

Dizziness

Anxiety

Insomnia

Haemoptysis

Wheezing

Rash

Hypotension

Amylase increased

Night sweats

Urticaria

Toothache

Discomfort

Performance status decreased

Hypersensitivity

Asthenopia

Dry Eye

Eye Pain

Retinal exudates

Anorectal infection

Candida infection

Gingivitis

Herpes zoster

Pharygitis

Blood cortisol decreased

Blood glucose increased

Blood urea increased

Ostenonecrosis of jaw

Pain in jaw

Lethargy

Neuralgia

Depressive symptom

Disorientation

Lichenoid keratosis

Pruitus generalised

Lymph node pain

Ligament sprain

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 3A(Arm)/ PD1-NSCLC (Phase 2)

DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation)

DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation)

DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation)

Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3

Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3

Cohort 3B(Arm)/ PD1-NSCLC (Phase 2)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Level 2 (DL2)Experimental Treatment3 Interventions

DL2 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.3mg/kg for the induction phase. After 4 cycles we will treat with 360mg of nivolumab and APX005M every 3 weeks.

Group II: Dose Level 1 (DL1)Experimental Treatment3 Interventions

DL1 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.1mg/kg for the induction phase. After 4 cycles, participants will be treated with 360mg of nivolumab and APX005M every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140