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Anti-tumor antibiotic
ALX148 + Chemotherapy + Immunotherapy for Ovarian Cancer
Phase 2
Recruiting
Led By Haider Mahdi, MD
Research Sponsored by Haider Mahdi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have recurrent epithelial ovarian cancer.
Known BRCA status or willing to be tested.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years (cohort); at 12 weeks (patient)
Awards & highlights
Study Summary
This trial is testing a new immunotherapy that may be more effective and have fewer side effects than current treatments.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in various organs (colitis or pneumonitis), infusion reactions from the drugs being administered, fatigue, blood disorders, increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian cancer has come back.
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I know my BRCA gene status or am willing to get tested.
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I have had up to 3 treatments for cancer that did not respond to platinum-based therapy.
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I have had up to 5 previous treatments for my condition.
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I am a woman over 18 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is one of the specified types, like high grade serous or clear cells.
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My cancer came back within 6 months after platinum-based treatment, but it wasn't initially resistant.
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My organ and bone marrow functions are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years (cohort); at 12 weeks (patient)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years (cohort); at 12 weeks (patient)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Objective response rate Immune-related Response Criteria (iRECIST)
Overall Survival (OS)
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,957 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,569 Patients Enrolled for Ovarian Cancer
Haider MahdiLead Sponsor
5 Previous Clinical Trials
162 Total Patients Enrolled
3 Trials studying Ovarian Cancer
92 Patients Enrolled for Ovarian Cancer
ALX OncologyUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of immune-related bowel or lung conditions.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.I have brain metastases that need steroids for symptoms.I have not received any live vaccines in the last 4 weeks.I have an autoimmune disease treated with medication in the last 2 years.I have a history of Hepatitis B or an active Hepatitis C infection.I have had up to 3 treatments for cancer that did not respond to platinum-based therapy.I have had up to 5 previous treatments for my condition.Women who could become pregnant must have a negative pregnancy test before joining the study.I have had an organ or stem-cell transplant.I have been diagnosed with HIV.I have an immune system disorder or am on long-term steroids.I have not had any other type of cancer, or if I have, it meets specific exceptions.I am still experiencing side effects from previous treatments.My ovarian cancer has come back.I am currently receiving IV treatment for an infection.I do not have severe chronic conditions like immune colitis or psychiatric issues.I am a woman over 18 years old.You must have a specific amount of disease that can be measured and monitored.My cancer has spread to my brain or its coverings.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is one of the specified types, like high grade serous or clear cells.I have not had radiotherapy in the last 2 weeks.I am on low-dose steroids or local immunosuppressants only.I have an active heart condition.My cancer came back within 6 months after platinum-based treatment, but it wasn't initially resistant.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have been treated with specific immune system targeting drugs before.My cancer got worse within 3 months of starting platinum-based treatment.My cancer is either sarcoma, carcinosarcoma, or low-grade carcinoma.I have previously been treated with PLD.I am a woman of childbearing potential and my recent pregnancy test was positive.I have an autoimmune disease that could worsen with immune-stimulating treatments.My organ and bone marrow functions are normal.
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.
Research Study Groups:
This trial has the following groups:- Group 1: ALX148 + Doxorubicin (PLD) + Pembrolizumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patient slots available for this research endeavor?
"The information on clinicaltrials.gov confirms that this particular trial is not looking for new candidates at the moment; it was initially posted in August 2022, with its most recent update occurring two weeks ago. Nevertheless, there are 677 other studies actively recruiting patients across the globe right now."
Answered by AI
Has Pembrolizumab been officially sanctioned by the Food and Drug Administration?
"While the efficacy of pembrolizumab has yet to be established, there is evidence that it can provide a modicum of safety. As such, Power assigned it a score of 2 on its scale from 1-3."
Answered by AI
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