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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
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 belowSelect...
I have at least two melanoma lesions that can be injected, each larger than 10 mm.
Select...
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:Select...
I have not had a blood clot in an artery in the last 3 months.
Select...
I am on medication for an active autoimmune disease.
Select...
I have previously received treatments like anti-PD-1 or anti-PD-L1.
Select...
I am a woman who can become pregnant, am pregnant, or am nursing.
Select...
I am taking more than 7.5 mg/day of prednisone or its equivalent.
Select...
I do not have any serious infections.
Select...
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
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 • NCT0312378350%
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
7%
Tremor
7%
Dysgeusia
7%
Vocal cord paralysis
7%
Deep vein thrombosis
7%
Blood alkaline phosphatase increased
7%
Cardiac arrest
7%
Pericardial effusion
7%
Blood creatinine increased
7%
Cancer pain
7%
Brain oedema
7%
Encephalitis autoimmune
7%
Chronic obstructive pulmonary disease
7%
Pulmonary embolism
7%
Tachycardia
7%
Hypothyroidism
7%
Vision blurred
7%
Weight decreased
7%
Back pain
7%
Musculoskeletal chest pain
7%
Myalgia
7%
Neck pain
7%
Dizziness
7%
Anxiety
7%
Insomnia
7%
Haemoptysis
7%
Wheezing
7%
Rash
7%
Hypotension
7%
Amylase increased
7%
Night sweats
7%
Urticaria
7%
Toothache
7%
Discomfort
7%
Performance status decreased
7%
Hypersensitivity
7%
Asthenopia
7%
Dry Eye
7%
Eye Pain
7%
Retinal exudates
7%
Anorectal infection
7%
Candida infection
7%
Gingivitis
7%
Herpes zoster
7%
Pharygitis
7%
Blood cortisol decreased
7%
Blood glucose increased
7%
Blood urea increased
7%
Ostenonecrosis of jaw
7%
Pain in jaw
7%
Lethargy
7%
Neuralgia
7%
Depressive symptom
7%
Disorientation
7%
Lichenoid keratosis
7%
Pruitus generalised
7%
Lymph node pain
7%
Ligament sprain
100%
80%
60%
40%
20%
0%
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)
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 2
~2070
APX005M
2017
Completed Phase 2
~390
Find a Location
Who is running the clinical trial?
Pyxis OncologyUNKNOWN
Apexigen, Inc.Industry Sponsor
11 Previous Clinical Trials
598 Total Patients Enrolled
6 Trials studying Melanoma
318 Patients Enrolled for Melanoma
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,669 Total Patients Enrolled
105 Trials studying Melanoma
25,673 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a blood clot in an artery in the last 3 months.I've only had certain skin cancers, in-situ cervical cancer, non-anaplastic thyroid cancer, or have been cancer-free for 2 years.I agree to use effective birth control during and for 4 months after the study.You have a condition that weakens your immune system.I have at least two melanoma lesions that can be injected, each larger than 10 mm.I am 18 years old or older.I am fully active or can carry out light work.Your hemoglobin level is higher than 9 grams per deciliter.I have received experimental vaccines or immune therapies.My melanoma diagnosis comes from skin or mucosal areas, not the eye.Your white blood cell count is higher than 3000 per cubic millimeter.I am on medication for an active autoimmune disease.My cancer is at an advanced stage and cannot be removed by surgery.I haven't had cancer treatment or surgery in the last 28 days, except for certain palliative care.I have had pembrolizumab or PD-1/L1 therapy, but it's been 6 months since my last dose.I have previously received treatments like anti-PD-1 or anti-PD-L1.Your platelet count is at least 100,000 per cubic millimeter.I am a woman who can become pregnant, am pregnant, or am nursing.Your liver enzymes (ALT and AST) are within a certain range, and if your liver is affected by the tumor, they are within a slightly higher range.Your absolute neutrophil count (ANC) is at least 1500 per cubic millimeter.My brain metastases are treated, stable, and I have no symptoms.I am taking more than 7.5 mg/day of prednisone or its equivalent.You do not have HIV antibodies in your blood.Your total bilirubin level should be less than 2.0 mg/dl, unless you have Gilbert's Syndrome, in which case it should be less than 3.0 mg/dl.I do not have any serious infections.You have a blood clotting problem that is currently active.I have severe heart failure or had a heart attack in the last 6 months.Your blood creatinine level is less than or equal to 2.0 mg/dl.I have a history of blood cancer.
Research Study Groups:
This trial has the following groups:- Group 1: APX005M + Pembrolizumab
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.
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