APX005M for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale Cancer Center, New Haven, CTMelanoma+1 MoreAPX005M - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Advanced Melanoma
  • Kidney Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
bland embolization
1
Arm A
1
Phase II ARRY-614 + nivolumab+ipilimumab (melanoma)

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Adverse Events Frequency
Adverse Events Rate
Dose-limiting toxicities
Recommended dose of APX005M

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
bland embolization
2
Arm A
1
Phase II ARRY-614 + nivolumab+ipilimumab (melanoma)

Side Effects for

Gem/NP/Nivolumab
75%Fatigue
72%Nausea
61%Anaemia
61%Decreased appetite
53%Diarrhoea
53%Aspartate aminotransferase increased
50%Alanine aminotransferase increased
47%Rash
44%Constipation
44%Pyrexia
42%Cough
42%Abdominal pain
42%Oedema peripheral
39%Alopecia
39%Vomiting
36%Dyspnoea
36%Neutrophil count decreased
36%Platelet count decreased
31%Weight decreased
28%Neuropathy peripheral
28%White blood cell count decreased
25%Anxiety
25%Blood alkaline phosphatase increased
25%Dehydration
25%Thrombocytopenia
22%Epistaxis
22%Headache
22%Hypotension
22%Neutropenia
22%Peripheral sensory neuropathy
19%Hypoalbuminaemia
19%Dizziness
19%Abdominal pain upper
19%Insomnia
17%Chills
17%Arthralgia
17%Blood bilirubin increased
17%Back pain
17%Depression
17%Lymphocyte count decreased
14%Blood creatinine increased
14%Abdominal distension
14%Hypokalaemia
14%Pruritus
14%Stomatitis
11%Rash maculo-papular
11%Gastrooesophageal reflux disease
11%Dysgeusia
11%Abdominal pain lower
11%Eructation
11%Hyperglycaemia
11%Hypertension
11%Hyponatraemia
11%Pleural effusion
11%Presyncope
11%Urinary tract infection
8%Hypocalcaemia
8%Hypoxia
8%Malaise
8%Dry mouth
8%Fall
8%Leukocytosis
8%Mucosal inflammation
8%Muscular weakness
8%Myalgia
8%Pain
8%Pain in extremity
8%Peripheral motor neuropathy
8%Rhinorrhoea
6%Cellulitis
6%Candida infection
6%Oropharyngeal pain
6%Blood creatine phosphokinase increased
6%Malnutrition
6%Dyspepsia
6%Asthenia
6%Deep vein thrombosis
6%Cardiac failure
6%Dry eye
6%Enterocolitis
6%Respiratory failure
6%Thrombotic microangiopathy
6%Dysphonia
6%Early satiety
6%Flank pain
6%Flatulence
6%Hot flush
6%Hyperkalaemia
6%Hypomagnesaemia
6%Hypophosphataemia
6%Hypothyroidism
6%Influenza like illness
6%Infusion related reaction
6%Nail disorder
6%Nasal congestion
6%Palpitations
6%Pneumonia
6%Productive cough
6%Sinusitis
6%Tachycardia
6%Upper-airway cough syndrome
6%Vision blurred
3%Liver abscess
3%Pneumonia staphylococcal
3%Pneumonitis
3%Staphylococcal infection
3%Acute coronary syndrome
3%Ascites
3%Bacteraemia
3%Demyelinating polyneuropathy
3%Diplopia
3%Duodenal obstruction
3%Haemoptysis
3%IIIrd nerve disorder
3%Immune-mediated pneumonitis
3%Myocarditis
3%Neutropenic sepsis
3%Pneumothorax
3%Systemic inflammatory response syndrome
This histogram enumerates side effects from a completed 2022 Phase 1 & 2 trial (NCT03214250) in the Gem/NP/Nivolumab ARM group. Side effects include: Fatigue with 75%, Nausea with 72%, Anaemia with 61%, Decreased appetite with 61%, Diarrhoea with 53%.

Trial Design

2 Treatment Groups

Dose Level 1 (DL1)
1 of 2
Dose Level 2 (DL2)
1 of 2

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: APX005M · No Placebo Group · Phase 1

Dose Level 1 (DL1)Experimental Group · 3 Interventions: Ipilimumab, APX005M, Nivolumab · Intervention Types: Drug, Drug, Drug
Dose Level 2 (DL2)Experimental Group · 3 Interventions: Ipilimumab, APX005M, Nivolumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Sotigalimab
Not yet FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,711 Previous Clinical Trials
20,477,991 Total Patients Enrolled
15 Trials studying Melanoma
760 Patients Enrolled for Melanoma
Apexigen, Inc.Industry Sponsor
11 Previous Clinical Trials
630 Total Patients Enrolled
6 Trials studying Melanoma
332 Patients Enrolled for Melanoma
Harriet Kluger, MD4.317 ReviewsPrincipal Investigator - Yale University
Yale University
5 Previous Clinical Trials
172 Total Patients Enrolled
5 Trials studying Melanoma
172 Patients Enrolled for Melanoma
5Patient Review
Dr. Kluger is my go-to physician for everything — she has never let me down. I would recommend her to anyone without hesitation.
Sarah Weiss, MDPrincipal InvestigatorYale University
Kelly Olino, MDPrincipal InvestigatorYale University

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least six more months.
You have had cancer that has spread to your brain before, but it must have been treated and stable for at least 4 weeks.
You are willing to provide a preserved sample of your tissue for research purposes, if it's available.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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