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

Trial Summary

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.

What data supports the effectiveness of the drug ALX148 + Chemotherapy + Immunotherapy for ovarian cancer?

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 other treatments, indicating its potential effectiveness. Additionally, doxorubicin is known to be active in treating ovarian cancer, and its combination with other drugs is being explored to improve outcomes.12345

What safety data exists for ALX148, doxorubicin, and pembrolizumab in humans?

Doxorubicin, a chemotherapy drug, can cause side effects like myelosuppression (reduced blood cell production), cardiotoxicity (heart damage), and nausea. Liposomal formulations of doxorubicin may have fewer side effects, but still require careful monitoring for issues like hand-foot syndrome. Pembrolizumab, an immunotherapy, is generally well-tolerated but can cause immune-related side effects.26789

What makes the drug combination of ALX148, Doxorubicin, and Pembrolizumab unique for treating ovarian cancer?

This treatment combines ALX148, a novel agent, with Doxorubicin and Pembrolizumab, which are known for their roles in chemotherapy and immunotherapy, respectively. The unique aspect is the combination of these drugs, potentially enhancing the immune response against ovarian cancer while utilizing the targeted delivery and reduced toxicity profile of liposomal doxorubicin.34101112

What is the purpose of this trial?

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

Research Team

UPMC Hillman Cancer Center

Alexander B. Olawaiye

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ALX148 + Doxorubicin (PLD) + PembrolizumabExperimental Treatment3 Interventions
Given on Day 1 of each 21 day cycle, in the following order of administration: 200 mg IV pembrolizumab\* (maximum of 2 years (approximately 35 cycles) 45 mg/kg IV ALX148 30 mg/m\^2 IV doxorubicin (Pegylated Liposomal Doxorubicin (PLD)\* \*standard of care

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

πŸ‡ΊπŸ‡Έ
Approved in United States as Adriamycin for:
  • Breast cancer
  • Ovarian cancer
  • Bladder cancer
  • Lymphomas
  • Leukemias
  • Multiple myeloma
  • Kaposi's sarcoma
  • Soft tissue sarcomas
πŸ‡ͺπŸ‡Ί
Approved in European Union as Doxorubicin for:
  • Breast cancer
  • Ovarian cancer
  • Bladder cancer
  • Lymphomas
  • Leukemias
  • Multiple myeloma
  • Kaposi's sarcoma
  • Soft tissue sarcomas
πŸ‡¨πŸ‡¦
Approved in Canada as Doxorubicin for:
  • Breast cancer
  • Ovarian cancer
  • Bladder cancer
  • Lymphomas
  • Leukemias
  • Multiple myeloma
  • Kaposi's sarcoma
  • Soft tissue sarcomas
πŸ‡―πŸ‡΅
Approved in Japan as Doxorubicin for:
  • Breast cancer
  • Ovarian cancer
  • Bladder cancer
  • Lymphomas
  • Leukemias
  • Multiple myeloma
  • Kaposi's sarcoma
  • Soft tissue sarcomas

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

Findings from Research

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]
The combination of doxorubicin, carboplatin, and weekly paclitaxel in treating advanced epithelial ovarian cancer (EOC) shows activity, with 4 out of 12 patients achieving partial remission and 3 having stable disease.
The main toxicity observed was myelosuppression, particularly grade 4 neutropenia, but the weekly administration of paclitaxel allowed for maintaining an effective dose intensity (approximately 65 mg/mΒ²/week) while managing side effects.
Phase I study of carboplatin, doxorubicin and weekly paclitaxel in patients with advanced ovarian carcinoma.Hess, V., Verrill, MW., Bomphray, CC., et al.[2020]
Paclitaxel has been established as an effective treatment for newly diagnosed ovarian cancer patients, leading to its incorporation into primary chemotherapy regimens, particularly in combination with cisplatin as the new standard in the U.S.
Ongoing clinical trials are exploring various strategies to optimize paclitaxel-based chemotherapy, including comparisons of different platinum-based drugs and infusion schedules, as well as evaluating high-dose therapies with stem cell support.
Chemotherapy of advanced ovarian cancer: current status and future directions.Ozols, RF., Vermorken, JB.[2015]

References

Innovative therapies for advanced ovarian cancer. [2012]
Phase I study of carboplatin, doxorubicin and weekly paclitaxel in patients with advanced ovarian carcinoma. [2020]
Chemotherapy of advanced ovarian cancer: current status and future directions. [2015]
Phase III data on Caelyx in ovarian cancer. [2019]
Phase II study of liposomal doxorubicin in advanced gynecologic cancers. [2013]
Phase 2 trial of liposomal doxorubicin (40 mg/m(2)) in platinum/paclitaxel-refractory ovarian and fallopian tube cancers and primary carcinoma of the peritoneum. [2022]
Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system. [2022]
Paeonol protects against doxorubicin-induced cardiotoxicity by promoting Mfn2-mediated mitochondrial fusion through activating the PKCΞ΅-Stat3 pathway. [2023]
Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The clinical utility of liposomal doxorubicin in recurrent ovarian cancer. [2014]
Caelyx/Doxil for the treatment of metastatic ovarian and breast cancer. [2022]
Cisplatin, paclitaxel and escalating doses of doxorubicin (TAP) in advanced ovarian cancer: a phase I trial. [2019]
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.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security