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Monoclonal Antibodies
APX005M + Nivolumab + Ipilimumab for Melanoma
Phase 1
Recruiting
Led By Kelly Olino, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I've had radiation therapy but not with radiopharmaceuticals in the last 8 weeks.
Select...
I can do most of my daily activities without help.
Select...
I am willing to have a tumor biopsy before and during the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicities
Recommended dose of APX005M
Secondary outcome measures
Adverse Events Frequency
Adverse Events Rate
Side effects data
From 2020 Phase 1 & 2 trial • 140 Patients • NCT0312378367%
Decreased appetite
67%
Chills
67%
Anaemia
67%
Fatigue
67%
Vomiting
67%
Oedema peripheral
67%
Pyrexia
67%
Dry skin
33%
Lung infection
33%
Hyperglycaemia
33%
Diarrhoea
33%
Lymphocyte count decrease
33%
Weight increased
33%
Blister
33%
Arthralgia
33%
Hypotension
33%
Acute kidney injury
33%
Rash maculo-papular
33%
Skin infection
33%
Skin hypopigmentation
33%
Headache
33%
Alanine aminotransferase increased
33%
Back pain
33%
Myalgia
33%
Aspartate aminotransferase increased
33%
Atrial Fibrillation
33%
Dehydration
33%
Autoimmune hepatitis
33%
Blood alkaline phosphatase increased
33%
Pneumonia
33%
Optic ischaemic neuropathy
33%
Insomnia
33%
Contusion
33%
Nausea
33%
Pain
33%
Hyperhidrosis
33%
Flushing
33%
Haematuria
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)
Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3
DL3 - APX005M 0.3 mg/kg + Nivolumab (Phase 1b Escalation)
DL1 - APX005M 0.03 mg/kg + Nivolumab (Phase 1b Escalation)
Cohort 3A(Arm)/ PD1-NSCLC (Phase 2)
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
APX005M
2017
Completed Phase 2
~350
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Apexigen America, Inc.Industry Sponsor
11 Previous Clinical Trials
604 Total Patients Enrolled
6 Trials studying Melanoma
324 Patients Enrolled for Melanoma
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,177 Total Patients Enrolled
15 Trials studying Melanoma
761 Patients Enrolled for Melanoma
Apexigen, Inc.Industry Sponsor
11 Previous Clinical Trials
604 Total Patients Enrolled
6 Trials studying Melanoma
324 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lung inflammation that is not caused by an infection.I have HIV, HBV, or HCV infection.I've had severe nerve, heart, or liver side effects from previous cancer immunotherapy.I've had radiation therapy but not with radiopharmaceuticals in the last 8 weeks.You are expected to live for at least 6 more months.I am using or willing to use effective birth control or I am not able to have children.I have not received a live vaccine in the last 30 days.Women who can have children need to have a negative pregnancy test before starting the study. If the urine test is positive or not clear, they will need a blood test to confirm.I've had immune therapy for advanced disease, but it's been 6 months since my last dose.I haven't had immune therapy for my advanced disease, but I may have had targeted therapy.I can do most of my daily activities without help.I have a tumor that can be measured on a scan and it's not in an area treated by radiation unless it has grown.I have not had a heart attack or unstable chest pain in the last 3 months.I have a tumor that can be biopsied, or it's been discussed with the study leads.My organs are functioning normally.I have brain metastases that have not been treated.I am not currently in any other clinical trials or have been in one within the last 4 weeks.I am over 18 and can understand and sign a consent form.My cancer has spread to the lining of my brain and spinal cord.I am not pregnant or breastfeeding.I do not have any open wounds or active skin infections.I am willing to have a tumor biopsy before and during the treatment.I agree to use birth control during and for 7 months after the study.I had major surgery over 2 weeks ago and have fully recovered with no open wounds.I have mostly recovered from side effects of previous treatments, except for hair loss.My brain metastases have been stable for at least 4 weeks.I am not using steroids for immune side effects and haven't used them for 2 weeks.I have an autoimmune disease treated with strong medication in the last year.I do not have any other active cancers besides the one being studied, except for skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1 (DL1)
- Group 2: Dose Level 2 (DL2)
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.
What pathologies is APX005M designed to address?
"APX005M is frequently administered to treat anti-angiogenic therapy, but it can also be beneficial for patients with unresectable melanoma, squamous cell carcinoma, and other malignant neoplasms."
Answered by AI
To what extent is the current clinical trial being utilized by participants?
"Affirmative. According to the information provided on clinicaltrials.gov, this investigation is actively recruiting participants with its first post dated September 14th 2020 and most recent update from November 22nd 2022. In total, 36 individuals are needed at 2 medical facilities for enrollment in this examination."
Answered by AI
What have other researchers discovered through investigations of APX005M?
"Currently, 769 research studies for APX005M are being conducted; 86 of those live clinical trials fall within the Phase 3 category. The majority of these investigations take place in Pittsburgh, Pennsylvania though there are 42779 other locations that feature similar experiments with this medication."
Answered by AI
Are there any open slots available for participants in this experiment?
"Indeed, the clinicaltrials.gov website shows that this trial is currently inviting participants to join. The investigation was first advertised on September 14th 2020 and has since been updated on November 22nd 2022. Across two sites, a total of 36 patients are needed for inclusion in the study."
Answered by AI
Is APX005M a reliable and secure therapeutic option?
"The lack of prior clinical data surrounding APX005M's safety and efficacy warrants a score of 1."
Answered by AI
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