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Monoclonal Antibodies
APX005M + Nivolumab + Ipilimumab for Melanoma
Phase 1
Waitlist Available
Led By Harriet Kluger, 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
Must not have
Active (non-infectious) pneumonitis.
Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) acute or chronic infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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I can do most of my daily activities without help.
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I am willing to have a tumor biopsy before and during the treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have lung inflammation that is not caused by an infection.
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I have HIV, HBV, or HCV infection.
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I've had severe nerve, heart, or liver side effects from previous cancer immunotherapy.
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I have not had a heart attack or unstable chest pain in the last 3 months.
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I have brain metastases that have not been treated.
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I am not currently in any other clinical trials or have been in one within the last 4 weeks.
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My cancer has spread to the lining of my brain and spinal cord.
Select...
I do not have any open wounds or active skin infections.
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I have an autoimmune disease treated with strong medication in the last year.
Select...
I do not have any other active cancers besides the one being studied, except for skin cancer.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicities
Recommended dose of APX005M
Secondary study objectives
Adverse Events Frequency
Adverse Events Rate
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%
Vocal cord paralysis
7%
Tremor
7%
Deep vein thrombosis
7%
Dysgeusia
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140
APX005M
2017
Completed Phase 2
~390
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
1,913 Previous Clinical Trials
3,039,456 Total Patients Enrolled
15 Trials studying Melanoma
750 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.
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