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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 • NCT0312378367%
Chills
67%
Decreased appetite
67%
Fatigue
67%
Oedema peripheral
67%
Vomiting
67%
Anaemia
67%
Pyrexia
67%
Dry skin
33%
Diarrhoea
33%
Lung infection
33%
Lymphocyte count decrease
33%
Weight increased
33%
Hyperglycaemia
33%
Hypotension
33%
Blister
33%
Arthralgia
33%
Acute kidney injury
33%
Rash maculo-papular
33%
Skin infection
33%
Skin hypopigmentation
33%
Headache
33%
Back pain
33%
Myalgia
33%
Aspartate aminotransferase increased
33%
Atrial Fibrillation
33%
Pain
33%
Dehydration
33%
Autoimmune hepatitis
33%
Blood alkaline phosphatase increased
33%
Pneumonia
33%
Optic ischaemic neuropathy
33%
Insomnia
33%
Contusion
33%
Hyperhidrosis
33%
Flushing
33%
Haematuria
33%
Alanine aminotransferase increased
33%
Nausea
33%
Tachycardia
33%
Abdominal pain
33%
Cytokine release syndrome
33%
Weight decreased
33%
Dizziness
33%
Cough
33%
Nasal congestion
33%
Pruritus
33%
Rash
33%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3
Cohort 3B(Arm)/ PD1-NSCLC (Phase 2)
DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3
DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 3A(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
~2010
APX005M
2017
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Pyxis OncologyUNKNOWN
Apexigen, Inc.Industry Sponsor
11 Previous Clinical Trials
608 Total Patients Enrolled
6 Trials studying Melanoma
328 Patients Enrolled for Melanoma
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,285 Total Patients Enrolled
102 Trials studying Melanoma
25,282 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide a synopsis of other research done involving APX005M?
"Presently, there are 967 ongoing clinical trials exploring APX005M with 122 of them in the late phase. Houston has a notable presence among the 35761 locations running studies for this drug, but it is not limited to that city alone."
Answered by AI
Are any medical facilities currently enrolling participants for this clinical research?
"Affirmative. Information hosted on clinicaltrials.gov verifies that this medical study is actively looking for subjects to enrol in the trial. The initial posting date was June 2nd 2017 and the last edit was made September 22nd 2022, with a need of 41 participants from one site being advertised."
Answered by AI
What is the current enrollment figure for this research study?
"Affirmative. According to the records from clinicaltrials.gov, this investigation is still actively recruiting patients and was first made available on June 2nd 2017. The trial seeks a total of 41 participants across one medical centre for enrollment."
Answered by AI
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