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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
Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study and for 4 months after the last dose of APX005M or Pembrolizumab such as: condom, diaphragm, hormonal, IUD, or sponge plus spermicide. Abstinence is an acceptable form of birth control
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
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 below
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I agree to use effective birth control during and for 4 months after the study.
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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.

Timeline

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

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 • NCT03123783
46%
Chills
43%
Asthenia
43%
Pyrexia
36%
Cough
29%
Alanine aminotransferase increased
29%
Aspartate aminotransferase increased
29%
Dyspnoea
29%
Nausea
25%
Decreased appetite
21%
Anaemia
18%
Arthralgia
18%
Gamma-glutamyltransferase increased
18%
Pain in extremity
18%
Vomiting
18%
Chest pain
14%
Pruritus
14%
Headache
14%
Respiratory tract infection
14%
Fatigue
11%
Blood alkaline phosphatase increased
11%
Infusion related reaction
11%
Haemoglobin decreased
11%
Weight decreased
11%
Hypotension
11%
Hypertension
7%
Sinusitis
7%
Hypercalcaemia
7%
Odynophagia
7%
Pneumonia
7%
Epistaxis
7%
Hyperhidrosis
7%
Amylase increased
7%
Diarrhoea
7%
Dysphagia
7%
Neck pain
7%
Nasopharyngitis
7%
Hypokalaemia
7%
Cytokine release syndrome
7%
Back pain
7%
Musculoskeletal pain
7%
Pulmonary embolism
7%
Flushing
7%
Tachycardia
7%
Oedema peripheral
4%
Hypomagnesaemia
4%
Bacteraemia
4%
Rhinorrhoea
4%
Femur fracture
4%
Bone pain
4%
Pharygitis
4%
Blood lactate dehydrogenase increased
4%
Fall
4%
Wheezing
4%
Sinus tachycardia
4%
Tremor
4%
Musculoskeletal chest pain
4%
Pneumonitis
4%
Rash
4%
Pancreatitis
4%
Dry mouth
4%
Haemoptysis
4%
Discomfort
4%
Gastritis
4%
Sepsis
4%
Hyperglycaemia
4%
Myositis
4%
Cancer pain
4%
Hyperthyroidism
4%
Abdominal pain upper
4%
Pain
4%
Blood bilirubin increased
4%
Blood creatinine increased
4%
Hyponatraemia
4%
Myalgia
4%
Dysphonia
4%
Productive cough
4%
Dehydration
4%
General physical health deterioration
4%
Herpes zoster
4%
Bronchitis
4%
Hypoxia
4%
Flank pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3B(Arm)/ PD1-NSCLC (Phase 2)
DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 3A(Arm)/ PD1-NSCLC (Phase 2)
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
DL2 - APX005M 0.1 mg/kg + Nivolumab (Phase 1b Escalation)
DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation)

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
~1950
APX005M
2017
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

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
2,958 Previous Clinical Trials
1,798,417 Total Patients Enrolled
102 Trials studying Melanoma
25,312 Patients Enrolled for Melanoma
Apexigen America, Inc.Industry Sponsor
11 Previous Clinical Trials
608 Total Patients Enrolled
6 Trials studying Melanoma
328 Patients Enrolled for Melanoma

Media Library

APX005M (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02706353 — Phase 1 & 2
Melanoma Research Study Groups: APX005M + Pembrolizumab
Melanoma Clinical Trial 2023: APX005M Highlights & Side Effects. Trial Name: NCT02706353 — Phase 1 & 2
APX005M (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02706353 — Phase 1 & 2

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 health benefits can be derived from regular use of APX005M?

"APX005M is a commonly used therapeutic agent to treat malignant neoplasms, as well as unresectable melanoma, microsatellite instability high diseases and cancer that has progressed after chemotherapy."

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
~4 spots leftby Apr 2025