26 Participants Needed

APX005M + Nivolumab + Ipilimumab for Melanoma

Recruiting at 1 trial location
HK
NS
Overseen ByNeta Shanwetter Levit, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires that any prior small molecule inhibitors be stopped at least 2 weeks before starting the study. If you are on corticosteroids, you must be off them for at least 2 weeks unless you are on a low dose for adrenal insufficiency. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug combination APX005M, Nivolumab, and Ipilimumab for treating melanoma?

Research shows that combining nivolumab and ipilimumab, which are part of this treatment, leads to better outcomes in advanced melanoma, including longer survival and higher response rates, compared to using ipilimumab alone.12345

Is the combination of APX005M, Nivolumab, and Ipilimumab safe for humans?

The combination of Nivolumab and Ipilimumab, used for treating melanoma, is associated with a higher risk of immune-related side effects, which can be severe but are often reversible with treatment. Close monitoring and experienced management are necessary to handle these side effects effectively.678910

What makes the drug combination of APX005M, Nivolumab, and Ipilimumab unique for treating melanoma?

This drug combination is unique because it combines APX005M with Nivolumab and Ipilimumab, which are known to enhance the immune system's ability to fight melanoma by targeting different immune checkpoints, potentially leading to better outcomes than using Ipilimumab alone.123511

What is the purpose of this trial?

This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.

Research Team

Harriet Kluger, MD < Yale School of ...

Harriet Kluger, MD

Principal Investigator

Yale University

SW

Sarah Weiss, MD

Principal Investigator

Yale University

KO

Kelly Olino, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

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.
See 12 more

Exclusion Criteria

Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study.
I have lung inflammation that is not caused by an infection.
I have HIV, HBV, or HCV infection.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M for 4 cycles

12 weeks
4 visits (in-person, every 3 weeks)

Maintenance Treatment

Participants receive nivolumab 360mg and APX005M every 3 weeks

Ongoing until disease progression or unacceptable toxicity
Visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

  • APX005M
  • Ipilimumab
  • Nivolumab
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Apexigen America, Inc.

Industry Sponsor

Trials
12
Recruited
630+

Apexigen, Inc.

Industry Sponsor

Trials
12
Recruited
630+

Findings from Research

In a phase 2 trial involving 142 patients with untreated advanced melanoma, the combination of nivolumab and ipilimumab resulted in a 2-year overall survival rate of 63.8%, compared to 53.6% for those receiving ipilimumab alone, suggesting improved survival outcomes with the combination therapy.
However, the combination treatment was associated with a higher incidence of severe side effects, with 54% of patients experiencing grade 3-4 adverse events compared to 20% in the ipilimumab-only group, indicating a trade-off between efficacy and safety.
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.Hodi, FS., Chesney, J., Pavlick, AC., et al.[2022]
In a phase 1 trial involving 53 patients with advanced melanoma, the combination of nivolumab and ipilimumab resulted in a 40% objective response rate, with 65% of patients showing clinical activity, indicating significant effectiveness in tumor reduction.
The concurrent treatment had a manageable safety profile, with 53% of patients experiencing grade 3 or 4 adverse events, which were similar to those seen with monotherapy and generally reversible, suggesting that this combination therapy is a viable option for patients.
Nivolumab plus ipilimumab in advanced melanoma.Wolchok, JD., Kluger, H., Callahan, MK., et al.[2022]
In a study of 142 patients with advanced melanoma, the combination of nivolumab and ipilimumab resulted in a significantly higher objective response rate of 61% compared to 11% for ipilimumab alone, indicating that the combination therapy is much more effective for treating this type of cancer.
While the combination therapy showed promising efficacy, it also had a higher incidence of severe adverse events (54% vs. 24% for monotherapy), but most of these side effects were manageable with immune-modulating medications.
Nivolumab and ipilimumab versus ipilimumab in untreated melanoma.Postow, MA., Chesney, J., Pavlick, AC., et al.[2022]

References

Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. [2022]
Nivolumab plus ipilimumab in advanced melanoma. [2022]
Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. [2022]
Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. [2023]
Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors. [2019]
Combined immune checkpoint blockade (anti-PD-1/anti-CTLA-4): Evaluation and management of adverse drug reactions. [2022]
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. [2022]
Association of immune-checkpoint inhibitors and the risk of immune-related colitis among elderly patients with advanced melanoma: real-world evidence from the SEER-Medicare database. [2022]
Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations. [2022]
11.Georgia (Republic)pubmed.ncbi.nlm.nih.gov
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)]. [2021]
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