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Monoclonal Antibodies

APX005M + Nivolumab + Ipilimumab for Melanoma

Phase 1
Waitlist Available
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
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

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 below
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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:
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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.
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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.
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I do not have any other active cancers besides the one being studied, except for skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 • NCT03123783
68%
Pyrexia
50%
Chills
47%
Nausea
39%
Fatigue
34%
Pruritus
29%
Alanine aminotransferase increased
26%
Vomiting
26%
Rash
24%
Aspartate aminotransferase increased
21%
Headache
18%
Gamma-glutamyltransferase increased
18%
Blood alkaline phosphatase increased
16%
Myalgia
16%
Diarrhoea
16%
Arthralgia
16%
Asthenia
13%
Constipation
11%
Anaemia
11%
Malaise
11%
Decreased appetite
11%
Upper respiratory tract infection
11%
Back pain
11%
Hypotension
8%
Pain in extremity
8%
Oedema peripheral
8%
Cough
8%
Infusion related reaction
8%
Flushing
8%
Blood lactate dehydrogenase increased
8%
Blood bilirubin increased
8%
Dyspnoea
5%
Chromaturia
5%
Hypothyroidism
5%
Nasal congestion
5%
Tachycardia
5%
Dry mouth
5%
Musculoskeletal chest pain
5%
Urinary tract infection
5%
Hypertension
5%
Amylase increased
5%
Palpitations
5%
Vertigo
5%
Dysuria
5%
Pneumonitis
5%
Abdominal pain
5%
Dyspepsia
5%
Dizziness
5%
Dysgeusia
5%
Dysphonia
5%
Ear Pain
5%
Dry skin
3%
Dysphagia
3%
Hyponatraemia
3%
Hyperglycaemia
3%
Infuenza
3%
Rash maculo-papular
3%
Localised infection
3%
Platelet count decreased
3%
Haemoglobin decreased
3%
Tremor
3%
Lipase increased
3%
Toothache
3%
Fungal infection
3%
Muscle rigidity
3%
Bacteraemia
3%
Blood creatinine increased
3%
Sinus tachycardia
3%
Blood glucose increased
3%
Pleural effusion
3%
Appendicitis
3%
Influenza like illness
3%
Nasopharyngitis
3%
Anxiety
3%
Dry Eye
3%
Intestinal obstruction
3%
Pain
3%
Toxicity to various agents
3%
Wheezing
3%
Insomnia
3%
Abdominal pain upper
3%
Hypoaesthesia
3%
Radius fracture
3%
Musculoskeletal pain
3%
Confusional state
3%
Hyperthyroidism
3%
Vision blurred
3%
Chest pain
3%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2(Arm)/ PD1-MM (Phase 2) - Includes Data From 2 Participants From DL3
Cohort 3B(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)
Cohort 1(Arm)/ inNSCLC (Phase 2) - Includes Data From 1 Participant From DL3
DL3 - APX005M 0.3 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
~4740
Ipilimumab
2014
Completed Phase 3
~2610

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
1,874 Previous Clinical Trials
2,953,530 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

APX005M (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04495257 — Phase 1
Melanoma Research Study Groups: Dose Level 1 (DL1), Dose Level 2 (DL2)
Melanoma Clinical Trial 2023: APX005M Highlights & Side Effects. Trial Name: NCT04495257 — Phase 1
APX005M (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04495257 — Phase 1
~0 spots leftby Aug 2024