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Monoclonal Antibodies

APX005M + Pembrolizumab for Melanoma

Phase 1 & 2

Waitlist Available

Led By Adi Diab, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

At least two injectable lesions (amenable for direct injection or through the use of image guidance such ultrasound [US], CT or MRI) defined as any injectable cutaneous, subcutaneous, nodal, or visceral melanoma lesion >/= 10 mm in longest diameter

Age >/= 18 years

Must not have

History of arterial thrombosis within 3 months of starting study treatment

Active autoimmune disease requiring disease-modifying therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is for patients with metastatic melanoma who have not previously been treated with immunotherapy.

Who is the study for?

This study is for adults with metastatic melanoma that has spread and hasn't been treated with pembrolizumab or similar drugs before. Participants need to have good liver function, not be pregnant, agree to use contraception, and have a performance status indicating they are relatively active. They should not have had recent cancer treatments or surgeries, no history of certain heart conditions or severe infections.

What is being tested?

The trial is testing the highest dose of APX005M that can be safely given with FDA-approved pembrolizumab in patients with metastatic melanoma. The aim is to see if this drug combination helps control the disease better than current treatments. All participants will receive both drugs at MD Anderson Cancer Center.

What are the potential side effects?

While specific side effects aren't listed here, common ones from trials like this may include fatigue, nausea, skin reactions at injection sites, immune-related issues such as inflammation in organs due to activation of the immune system by these drugs.

Eligibility Criteria

Inclusion Criteria

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

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I have at least two melanoma lesions that can be injected, each larger than 10 mm.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My melanoma diagnosis comes from skin or mucosal areas, not the eye.

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My cancer is at an advanced stage and cannot be removed by surgery.

Exclusion Criteria

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

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I have not had a blood clot in an artery in the last 3 months.

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I am on medication for an active autoimmune disease.

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I have previously received treatments like anti-PD-1 or anti-PD-L1.

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I am a woman who can become pregnant, am pregnant, or am nursing.

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I am taking more than 7.5 mg/day of prednisone or its equivalent.

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I do not have any serious infections.

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I have a history of blood cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D) of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma - Dose Escalation Phase

Overall Response Rate (ORR) After Intratumoral Injection of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma - Dose Expansion Phase

Secondary study objectives

Immune-Related Best Overall Response (irBOR) of APX005M in Combination with Pembrolizumab in Participants with Metastatic Melanoma

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

Tremor

Dysgeusia

Vocal cord paralysis

Deep vein thrombosis

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

1Treatment groups

Experimental Treatment

Group I: APX005M + PembrolizumabExperimental Treatment2 Interventions

Dose Escalation Phase: Starting dose level of APX005M is 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses. Tumor site chosen based on volume to be injected. All participants receive Pembrolizumab at 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M. Dose Expansion Phase: Starting dose level of APX005M is maximum tolerated dose from Dose Escalation Phase. Participants receive same dosage of Pembrolizumab as in Dose Escalation Phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

APX005M

2017

Completed Phase 2

~390