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Monoclonal Antibodies
APX005M + Nivolumab + Cabiralizumab 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
RCC: Histologic or cytologically documented, locally advanced unresectable or metastatic RCC irrespective of histologic subtype
Biopsy proven metastatic melanoma, NSCLC or RCC whose disease has progressed on a prior regimen containing a PD-1 or PD-L1 inhibitor, without intervening therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment up to 6 years.
Awards & highlights
Study Summary
This trial is a study to see if a new combination of drugs is safe and effective in treating advanced solid tumors. The study will enroll patients with melanoma, NSCLC, and RCC to see if the new combination is better than current treatments.
Who is the study for?
Adults with advanced melanoma, NSCLC, or RCC who have measurable lesions and normal organ/marrow function. They must not be pregnant, agree to contraception use, and can't have untreated brain metastases or certain active infections. Prior treatments should be completed within specific timeframes before starting the study drugs.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: APX005M, Nivolumab, and Cabiralizumab in patients with advanced solid tumors. It includes an initial phase to find the best dose followed by a second phase focusing on each cancer type separately.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs, infusion-related symptoms like allergic responses or skin reactions, fatigue from treatment burden on the body's systems, as well as possible complications from pre-existing conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is advanced, cannot be surgically removed, or has spread.
Select...
My melanoma, NSCLC, or RCC has worsened after treatment with a PD-1 or PD-L1 inhibitor.
Select...
I can provide tissue samples from at least one cancer site.
Select...
My organs and bone marrow are functioning normally.
Select...
I have a tumor that can be measured by CT or MRI.
Select...
I can do most of my daily activities without help.
Select...
I have advanced melanoma that cannot be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study enrollment up to 6 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment up to 6 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
Secondary outcome measures
Efficacy Measured by Objective Response Rate (ORR)
Other outcome measures
Blood-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Circulating CD163+ Macrophages .
Blood-based Pharmacodynamics (PD) of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by Circulating CD8+ T Cells.
Cytokine-based Pharmacodynamic (PD) Biomarkers of APX005M, in Combination With Nivolumab and Cabiralizumab Assessed by CD40L Levels.
+11 moreSide effects data
From 2020 Phase 1 & 2 trial • 140 Patients • NCT0312378367%
Decreased appetite
67%
Fatigue
67%
Oedema peripheral
67%
Vomiting
67%
Anaemia
67%
Chills
67%
Pyrexia
67%
Dry skin
33%
Hyperglycaemia
33%
Weight increased
33%
Flushing
33%
Hypotension
33%
Blister
33%
Arthralgia
33%
Pain
33%
Diarrhoea
33%
Acute kidney injury
33%
Dehydration
33%
Rash maculo-papular
33%
Skin infection
33%
Skin hypopigmentation
33%
Haematuria
33%
Headache
33%
Back pain
33%
Myalgia
33%
Aspartate aminotransferase increased
33%
Atrial Fibrillation
33%
Autoimmune hepatitis
33%
Blood alkaline phosphatase increased
33%
Pneumonia
33%
Optic ischaemic neuropathy
33%
Insomnia
33%
Hyperhidrosis
33%
Lymphocyte count decrease
33%
Lung infection
33%
Contusion
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
9Treatment groups
Experimental Treatment
Group I: Cohort 9 RCCExperimental Treatment3 Interventions
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
Group II: Cohort 8 NSCLCExperimental Treatment2 Interventions
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
Group III: Cohort 7 Advanced MelanomaExperimental Treatment3 Interventions
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
Group IV: Cohort 6 Advanced Solid TumorsExperimental Treatment3 Interventions
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
Group V: Cohort 5 Advanced Solid TumorsExperimental Treatment2 Interventions
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
Group VI: Cohort 4 Advanced Solid TumorsExperimental Treatment3 Interventions
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
Group VII: Cohort 3 Advanced Solid TumorsExperimental Treatment2 Interventions
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
Group VIII: Cohort 2 Advanced Solid TumorsExperimental Treatment3 Interventions
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
Group IX: Cohort 1 Advanced Solid TumorsExperimental Treatment2 Interventions
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APX005M
2017
Completed Phase 2
~350
Cabiralizumab
2018
Completed Phase 2
~620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,486 Total Patients Enrolled
Apexigen America, Inc.Industry Sponsor
11 Previous Clinical Trials
598 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have muscle disorders or recent muscle injuries that affect my CK levels.I haven't had immune therapy or chemotherapy in the last 4 weeks and have recovered from any side effects.I have been treated with CSF1R inhibitors or CD40 agonists before.I haven't used steroids for immune issues for at least 2 weeks.I have brain metastases that have not been treated.I've had severe nerve, heart, or liver side effects from previous cancer immunotherapy.I still have side effects from previous treatments, except for minor issues like hair loss or mild nerve pain.My cancer has spread to the lining of my brain and spinal cord.I have other active cancers besides the one being studied.I have HIV, HBV, or HCV infection.I haven't had a heart attack or unstable chest pain in the last 3 months.I do not have any open wounds or active skin infections.My kidney cancer is advanced, cannot be surgically removed, or has spread.I can provide tissue samples from at least one cancer site.My advanced lung cancer has specific genetic changes and I've tried certain targeted therapies.I am using or willing to use effective birth control or abstain from sex for 5 months after the last study drug dose.I will use birth control during and for 7 months after my treatment.I have a tumor that can be measured by CT or MRI.I had radiotherapy but finished it at least 4 weeks ago if it was for my brain, lungs, or intestines.My melanoma, NSCLC, or RCC has worsened after treatment with a PD-1 or PD-L1 inhibitor.I am a woman who can have children and have a recent negative pregnancy test.My brain metastases have been stable for at least 4 weeks.I am willing to have two tumor biopsies for this study.My organs and bone marrow are functioning normally.I had surgery with general anesthesia over a week ago, or minor surgery over 3 days ago and have recovered.You have a current or past medical condition that could make it too risky to take the study drug, or a condition that could make it hard to understand the study results.I have not received a live vaccine in the last 30 days.I can do most of my daily activities without help.I am 18 or older and can understand and sign a consent form.You are expected to live for at least 6 months.I am currently taking statins.I have had cancer treatments, but none within the last 4 weeks (or 2 weeks for certain drugs).I have advanced melanoma that cannot be surgically removed.You have an ongoing autoimmune disease that needed treatment in the last year, and it's not related to the use of immune checkpoint inhibitors.I have lung inflammation that is not caused by an infection.I have uveal melanoma.I am not currently in any other clinical trials or have been in one within the last 4 weeks.You have had a severe allergic reaction to a previous biologic medication.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4 Advanced Solid Tumors
- Group 2: Cohort 8 NSCLC
- Group 3: Cohort 1 Advanced Solid Tumors
- Group 4: Cohort 2 Advanced Solid Tumors
- Group 5: Cohort 3 Advanced Solid Tumors
- Group 6: Cohort 5 Advanced Solid Tumors
- Group 7: Cohort 6 Advanced Solid Tumors
- Group 8: Cohort 7 Advanced Melanoma
- Group 9: Cohort 9 RCC
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.
Are there any known risks associated with utilizing APX005M in a medical setting?
"The safety of APX005M is estimated to be a 1 because this is an early-phase medical study, indicating that there has been limited research on its efficacy and the extent of its safety."
Answered by AI
Are there any previous investigations involving APX005M?
"Presently, 722 clinical trials exploring APX005M are in progress. Of these active studies, 82 have reached phase 3 status. The bulk of these research sites are based in Bern, BE; yet there are 40310 facilities studying this drug worldwide."
Answered by AI
What medical conditions has APX005M been found to be beneficial for?
"APX005M is typically used to address malignant neoplasms, yet it has also been applied to manage unresectable melanoma, squamous cell carcinomas, and metastatic esophageal adenocarcinoma."
Answered by AI
What is the current capacity for participants in this clinical trial?
"Currently, this research is not searching for more participants. Originally posted on the 9th of June 2018, and last updated two days ago, it has concluded its recruitment process. If you are looking to join a trial related to lung cancer there are currently 4887 studies that require volunteers; alternatively, 722 clinical trials are enrolling patients with APX005M."
Answered by AI
Is this experiment actively seeking participants at the moment?
"At present, this medical trial is not currently seeking new candidates. Originally posted on June 9th 2018 and last updated July 22nd 2022, patients should explore other opportunities to participate in a clinical trial by reviewing the 4887 trials for lung cancer or 722 studies associated with APX005M that are actively enrolling participants."
Answered by AI
Is this a pioneering research experiment?
"Since 2012, APX005M has been the focus of numerous trials and studies. The original investigation was conducted by Ono Pharmaceutical Co. Ltd., while subsequent Phase 1 & 2 drug approvals were granted in 2012 after 659 participants had completed their clinical trial protocols. At present, there are 722 active surveys on APX005M across 2356 cities distributed among 49 countries worldwide."
Answered by AI
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