31 Participants Needed

ALX148 + Chemotherapy + Immunotherapy for Ovarian Cancer

JP
KM
LB
Overseen ByLucia Borasso, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug combination for ovarian cancer that has returned and resists common platinum-based treatments. It combines chemotherapy and immunotherapy with ALX148 (Evorpacept), which may enhance the immune system's ability to target cancer cells. Individuals with recurrent epithelial ovarian cancer who have tried several treatments without success might be suitable candidates. Participation can help researchers determine if this new combination effectively shrinks tumors or slows their growth. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that prior systemic anti-cancer therapy should not have been taken within 4 weeks before starting the trial, and certain immunosuppressive therapies are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that using ALX148 with other treatments led to some serious side effects. Two patients died from rare immune system reactions linked to the trial drugs. However, other studies have shown that ALX148 can be safe with careful monitoring.

Doxorubicin, a common cancer treatment, is usually well-tolerated but can cause side effects like heart problems and low blood cell counts.

Pembrolizumab is also part of this trial. This immunotherapy drug treats various cancers and is generally considered safe, though some people might feel tired or have skin reactions.

This trial is in an early phase, so researchers are closely studying safety. While known risks exist, careful monitoring helps manage them.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of ALX148 with pembrolizumab and doxorubicin for ovarian cancer because it offers a novel approach to treatment. Unlike standard therapies, which often rely on surgery, chemotherapy, or single-agent immunotherapy, this regimen combines a new agent, ALX148, with existing drugs for a potentially more powerful effect. ALX148 works by blocking the CD47 protein, often referred to as a "don't eat me" signal that cancer cells use to evade the immune system. By combining this with pembrolizumab, an immune checkpoint inhibitor, and doxorubicin, a chemotherapy agent, the treatment aims to enhance the immune system's ability to target and destroy cancer cells more effectively. This multi-faceted approach could lead to better outcomes for patients with ovarian cancer.

What evidence suggests that ALX148 combined with chemotherapy and immunotherapy could be effective for ovarian cancer?

In this trial, participants will receive a combination of ALX148, doxorubicin, and pembrolizumab, which research suggests might be effective against ovarian cancer. ALX148 aids the immune system by blocking a protein called CD47, which cancer cells use to evade detection. This combination could enhance the immune system's ability to locate and attack cancer cells. Specifically, studies have shown that a special form of doxorubicin, called pegylated liposomal doxorubicin, helped 26% of ovarian cancer patients who did not respond to other treatments. Adding pembrolizumab, a drug that boosts the immune system, might increase the treatment's effectiveness. Overall, this combination aims to improve outcomes for patients with ovarian cancer that has not responded to standard treatments.14567

Who Is on the Research Team?

UPMC Hillman Cancer Center

Alexander B. Olawaiye

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with recurrent epithelial ovarian cancer that's resistant to platinum-based therapy. They must have had fewer than six prior treatments, an ECOG performance status of 0-1, and measurable disease. Participants need normal organ/marrow function, known BRCA status, and agree to contraception if applicable.

Inclusion Criteria

I know my BRCA gene status or am willing to get tested.
There is a preserved tumor tissue sample from when you were first diagnosed, or from a later site if the cancer spread.
Willing to use highly effective contraception throughout the study and for at least 4 months after last treatment administration if childbearing potential exists.
See 11 more

Exclusion Criteria

I have a history of immune-related bowel or lung conditions.
I have brain metastases that need steroids for symptoms.
Patients who are pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive Pegylated Liposomal Doxorubicin, pembrolizumab, and ALX148 every 21 days until disease progression or unacceptable toxicity

Up to 2 years

Maintenance Therapy

For patients with a complete response, maintenance therapy with pembrolizumab and ALX148 continues for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ALX148
  • Doxorubicin
  • Pembrolizumab
Trial Overview The trial tests ALX148 combined with liposomal doxorubicin and pembrolizumab in patients with ovarian cancer who've shown resistance to platinum therapies. It aims to enhance the effectiveness of immunotherapy by targeting CD47 on tumor cells.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ALX148 + Doxorubicin (PLD) + PembrolizumabExperimental Treatment3 Interventions

Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Adriamycin for:
🇪🇺
Approved in European Union as Doxorubicin for:
🇨🇦
Approved in Canada as Doxorubicin for:
🇯🇵
Approved in Japan as Doxorubicin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Haider Mahdi

Lead Sponsor

Trials
6
Recruited
130+

Alexander B Olawaiye, MD

Lead Sponsor

Trials
4
Recruited
130+

ALX Oncology

Collaborator

Trials
1
Recruited
30+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

In a phase I trial involving 28 patients with advanced ovarian cancer, the combination of doxorubicin, paclitaxel, and cisplatin was found to be feasible and well tolerated, with a clinical response observed in 84% of evaluable patients.
The maximum tolerated dose was not established, but the recommended dose for further studies was determined to be 50 mg/m² of doxorubicin, as the treatment showed manageable toxicity and significant efficacy.
Cisplatin, paclitaxel and escalating doses of doxorubicin (TAP) in advanced ovarian cancer: a phase I trial.Onda, T., Katsumata, N., Tsunematsu, R., et al.[2019]
Research is focusing on non-cross-resistant drugs like oxaliplatin and topotecan for treating drug-resistant ovarian cancer, with many being tested in combination therapies to improve outcomes.
Innovative strategies such as anticancer vaccines and gene therapy are being explored, highlighting the importance of clinical trials for women with advanced ovarian cancer due to low current cure rates.
Innovative therapies for advanced ovarian cancer.Trimble, EL.[2012]
In a phase II study involving 63 patients with ovarian cancer, pegylated liposomal doxorubicin (Doxil) showed a response rate of 19% in patients with measurable disease and a median overall survival of 10 months, indicating its efficacy in a heavily pretreated population.
Doxil was well tolerated, with manageable side effects; serious toxicities were relatively low, and nausea and vomiting were uncommon, suggesting a favorable safety profile compared to traditional chemotherapy.
Phase II study of liposomal doxorubicin in advanced gynecologic cancers.Israel, VP., Garcia, AA., Roman, L., et al.[2013]

Citations

Safety and Efficacy of Anti-CD47, ALX148 in Combination ...Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer.
ALX148 in Combination with Liposomal Doxorubicin and ...Giving ALX148 in combination with PLD and pembrolizumab may kill more tumor cells in patients with recurrent platinum-resistant ovarian cancer. Eligibility ...
Safety and Efficacy of Anti-CD47, ALX148 in Combination ...Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer. P2.
ALX Oncology Announces First Patient Dosed in Phase 2 ...We anticipate that the combination of evorpacept, liposomal doxorubicin and pembrolizumab may lead to improved efficacy and a more favorable ...
ALX148 + Chemotherapy + Immunotherapy for Ovarian ...Research shows that pegylated liposomal doxorubicin (a form of doxorubicin) has shown a 26% response rate in ovarian cancer patients who did not respond to ...
Results of a phase 2 study of evorpacept (E, ALX148), ...There were two on-study deaths assessed as related to all three study drugs (hemophagocytic lymphohistiocytosis and cytokine release syndrome; 1 ...
A Phase 1 Study of ALX148: CD47 Blockade in ...Patients experienced a best response of 1PR, 5SD (one SD >24weeks) with. 5 patients continuing on treatment. • HNSCC ALX148 + pembrolizumab: 4 evaluable ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security