Immunotherapy for Ovarian Cancer
(IPROC Trial)
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Canadian Cancer Trials Group
Must not be taking: Antivirals, Corticosteroids, Live vaccines
Disqualifiers: HIV, Hepatitis, Autoimmune, Cardiac, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This study is being done to answer the following question: What are the effects of a new drug or drugs on ovarian cancer? The pre-study screening may be done to test a sample of tissue for biomarkers to determine participation in the study.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, a minimum of 4 weeks must have passed since your last dose of prior therapy before enrollment, and any reversible side effects from previous treatments should have improved to a mild level. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug BA3011, Mecbotamab vedotin, and related antibody-drug conjugates for ovarian cancer?
Antibody-drug conjugates (ADCs) have shown promise in treating ovarian cancer by targeting specific proteins on cancer cells to deliver toxic drugs directly to them, minimizing harm to healthy cells. Some ADCs have been approved for use in gynecologic cancers, and others are in clinical trials with encouraging results, suggesting potential effectiveness for ovarian cancer.12345
What safety data exists for immunotherapy treatments like BA3011 and BA3021 in humans?
Antibody-drug conjugates (ADCs) like BA3011 and BA3021 have been tested in early-phase clinical trials for ovarian cancer, showing promising results with a favorable safety profile. Reported side effects include visual disturbances and neuropathy (nerve damage), but significant blood-related toxicities are not common.23467
What makes the drug BA3011, BA3021, and Durvalumab unique for ovarian cancer?
This treatment is unique because it involves antibody-drug conjugates (ADCs), which are a novel class of drugs that combine antibodies with cancer-killing agents, specifically targeting cancer cells while sparing healthy ones. This approach is different from traditional chemotherapy, which affects both cancerous and healthy cells.3891011
Research Team
AT
Anna Tinker
Principal Investigator
BCCA - Vancouver Cancer Centre, BC Canada
HM
Helen MacKay
Principal Investigator
Sunnybrook Health Sciences Centre, Toronto, Ontario Canada
Eligibility Criteria
This trial is for women with high grade serous ovarian cancer that's resistant to platinum-based chemotherapy. Participants must be over 18, have a life expectancy of at least 3 months, and an ECOG performance status of 0 or 1. They should not have uncontrolled illnesses or a history of severe autoimmune disorders in the past three years. Pregnant women and those who've had certain treatments recently are excluded.Inclusion Criteria
My organ and bone marrow functions are currently healthy.
All patients must be registered for screening prior to study enrollment, however, if biomarker testing results are not required prior to enrollment to a substudy, then enrollment can proceed immediately.
Any side effects from my previous treatments have mostly gone away.
See 19 more
Exclusion Criteria
I have not received a live vaccine in the last 4 weeks.
My heart's electrical cycle is longer than normal, or I take medications that can extend this cycle.
My cancer has spread to my brain.
See 5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive experimental immunotherapy drugs to assess their effects on ovarian cancer
8-12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- BA3011 (Monoclonal Antibodies)
- BA3021 (Monoclonal Antibodies)
- Durvalumab (Monoclonal Antibodies)
- To be determined (Other)
Trial OverviewThe study tests new drugs (BA3021, Durvalumab, BA3011) on ovarian cancer to see their effects. Patients will undergo pre-study screening for biomarkers which may determine their eligibility for specific substudies within the main trial.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: ENB-003 + ToripalimabExperimental Treatment2 Interventions
Group II: Durvalumab + BA3021 (Arm Closed)Experimental Treatment2 Interventions
Group III: Durvalumab + BA3011 (Arm Closed)Experimental Treatment2 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Jewish General HospitalMontreal, Canada
BCCA - KelownaKelowna, Canada
BCCA - VancouverVancouver, Canada
University Health NetworkToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
Trials
135
Patients Recruited
70,300+
Cancer Research Institute, New York City
Collaborator
Trials
22
Patients Recruited
1,300+
AstraZeneca
Industry Sponsor
Trials
4491
Patients Recruited
290,540,000+
BioAtla, Inc.
Industry Sponsor
Trials
7
Patients Recruited
1,500+
Findings from Research
Mirvetuximab Soravtansine (IMGN853) is an antibody drug conjugate that targets the folate receptor alpha and has shown promising effectiveness and a favorable safety profile in treating platinum-resistant ovarian cancer, particularly in patients with moderate-to-high FRα expression.
The ongoing phase III study comparing IMGN853 to standard chemotherapy aims to further establish its efficacy, while additional ADCs targeting other cancer markers are also being explored in early clinical trials, highlighting a growing strategy to enhance treatment for ovarian cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antibody-drug conjugates for ovarian cancer: current clinical development.Stewart, D., Cristea, M.[2019]
Antibody-drug conjugates (ADCs) are a promising cancer treatment that selectively deliver toxic drugs to tumor cells by targeting specific antigens, which helps reduce systemic toxicity compared to traditional chemotherapy.
Over 15 ADCs are currently being studied for ovarian cancer, with some showing promising results in early-phase clinical trials, indicating their potential effectiveness in treating this type of cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antibody-Drug Conjugates: A Promising Novel Therapy for the Treatment of Ovarian Cancer.Manzano, A., Ocaña, A.[2020]
The FDA has recently approved two antibody drug conjugates (ADCs) for gynecological cancers: tisotumab vedotin for recurrent cervical cancer and mirvetuximab soravtansine for platinum-resistant ovarian cancer, marking a significant advancement in treatment options.
Over 20 ADC formulations are currently in clinical trials for various gynecological tumors, highlighting the rapid expansion of this treatment class and the exploration of new targets and drug delivery methods.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Integrating antibody drug conjugates in the management of gynecologic cancers.Chelariu-Raicu, A., Mahner, S., Moore, KN., et al.[2023]
Anti-mesothelin antibody-drug conjugates show promise as a novel treatment for ovarian cancer, with encouraging results from phase II trials indicating their efficacy and favorable safety profiles.
These therapies target mesothelin, which is commonly expressed in ovarian cancers, but further phase III trials are needed to confirm their effectiveness in treating recurrent and advanced disease.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Novel mesothelin antibody-drug conjugates: current evidence and future role in the treatment of ovarian cancer.Mauricio, D., Harold, J., Tymon-Rosario, JR., et al.[2022]
The SGO Journal Club highlighted the recent FDA approval of two antibody-drug conjugates (ADCs) for treating cervical and ovarian cancer, showcasing their potential as new therapeutic options in gynecologic malignancies.
Discussions included the pharmacology and toxicities of ADCs, emphasizing the importance of understanding these factors in the context of clinical trials like GOG-3023 and the SORAYA study, which evaluated the efficacy and safety of Mirvetuximab Soravtansine in patients with platinum-resistant ovarian cancer.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Society of Gynecologic Oncology Journal Club: Controversial conversations in Gynecologic cancer - The ABCs of ADCs (Antibody drug Conjugates).Martin, J., Zacholski, E., O'Cearbhaill, R., et al.[2023]
Bevacizumab Vedotin, a novel antibody-drug conjugate, effectively targets tumors by combining the specificity of bevacizumab with the cytotoxic effects of MMAE, showing strong stability and tumor cell targeting in biological studies.
In vitro tests demonstrated that Bevacizumab Vedotin not only inhibits cancer cell proliferation and promotes apoptosis in various cancer cell lines but also enhances anti-migration activity and blocks the VEGF/VEGFR pathway, suggesting a promising therapeutic approach with potentially reduced systemic toxicity.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Discovery of novel antibody-drug conjugates bearing tissue protease specific linker with both anti-angiogenic and strong cytotoxic effects.Li, Y., Si, R., Wang, J., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Antibody Drug Conjugates in the Treatment of Epithelial Ovarian Cancer.Richardson, DL., Seward, SM., Moore, KN.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Double-Blind, Placebo-Controlled, Randomized Phase III Trial Evaluating Pertuzumab Combined With Chemotherapy for Low Tumor Human Epidermal Growth Factor Receptor 3 mRNA-Expressing Platinum-Resistant Ovarian Cancer (PENELOPE).Kurzeder, C., Bover, I., Marmé, F., et al.[2022]
The PENELOPE trial found that adding pertuzumab to chemotherapy for patients with platinum-resistant ovarian cancer did not significantly improve overall survival, with a hazard ratio of 0.90, indicating no meaningful difference between the treatment and control groups.
While pertuzumab did not enhance patient-reported outcomes overall, it was associated with increased diarrhea symptoms, suggesting a need for careful monitoring of side effects in patients receiving this treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer.Lorusso, D., Hilpert, F., González Martin, A., et al.[2022]
In a randomized phase II study involving 149 patients with platinum-sensitive recurrent advanced ovarian cancer, the addition of pertuzumab to carboplatin-based chemotherapy did not significantly improve progression-free survival (PFS) compared to chemotherapy alone.
Pertuzumab was well tolerated, showing no increase in cardiac adverse events, indicating it is a safe option to combine with chemotherapy despite not enhancing efficacy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer.Kaye, SB., Poole, CJ., Dańska-Bidzińska, A., et al.[2022]
The combination of mirvetuximab soravtansine and bevacizumab is well tolerated in patients with platinum-resistant ovarian cancer, with most adverse events being mild-to-moderate, including diarrhea and nausea.
This treatment showed a confirmed objective response rate of 39%, with particularly promising results (56% response rate) in patients who were less heavily pretreated and had higher levels of folate receptor alpha expression.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer.O'Malley, DM., Matulonis, UA., Birrer, MJ., et al.[2020]
References
Antibody-drug conjugates for ovarian cancer: current clinical development. [2019]
Antibody-Drug Conjugates: A Promising Novel Therapy for the Treatment of Ovarian Cancer. [2020]
Integrating antibody drug conjugates in the management of gynecologic cancers. [2023]
Novel mesothelin antibody-drug conjugates: current evidence and future role in the treatment of ovarian cancer. [2022]
Society of Gynecologic Oncology Journal Club: Controversial conversations in Gynecologic cancer - The ABCs of ADCs (Antibody drug Conjugates). [2023]
Discovery of novel antibody-drug conjugates bearing tissue protease specific linker with both anti-angiogenic and strong cytotoxic effects. [2023]
Antibody Drug Conjugates in the Treatment of Epithelial Ovarian Cancer. [2019]
Double-Blind, Placebo-Controlled, Randomized Phase III Trial Evaluating Pertuzumab Combined With Chemotherapy for Low Tumor Human Epidermal Growth Factor Receptor 3 mRNA-Expressing Platinum-Resistant Ovarian Cancer (PENELOPE). [2022]
Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. [2022]
A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer. [2022]
Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. [2020]