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Monoclonal Antibodies
Immunotherapy for Ovarian Cancer (IPROC Trial)
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All reversible prior toxicity must have recovered to grade ≤ 1.
This study will enroll women with platinum resistant high grade serous ovarian cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
IPROC Trial Summary
This trial is testing new drugs to see if they can treat ovarian cancer. They may do a pre-study screening to test a tissue sample for biomarkers to see if someone can participate.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects could include typical reactions associated with immunotherapy such as fatigue, skin reactions, inflammation in organs like lungs or intestines, hormonal gland problems (like thyroid), infusion-related reactions and possible worsening of autoimmune diseases.
IPROC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Any side effects from my previous treatments have mostly gone away.
Select...
I am a woman with ovarian cancer that is not responding to platinum-based chemotherapy.
Select...
I am mostly active and doctors expect me to live for at least 3 more months.
Select...
I am 18 years old or older.
Select...
I have agreed to provide a sample of my tumor for research.
IPROC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To efficiently identify based on objective response rate (ORR), by investigator assessment using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serous ovarian cancer for later validation in randomized trials
Secondary outcome measures
Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST)
Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST)
Evaluate ORR by investigator assessment using RECIST 1.1
+1 moreSide effects data
From 2022 Phase 3 trial • 867 Patients • NCT0308447126%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab
IPROC Trial Design
3Treatment groups
Experimental Treatment
Group I: Sub Study X (etc.)Experimental Treatment1 Intervention
Group II: Durvalumab + BA3021Experimental Treatment2 Interventions
Group III: Durvalumab + BA3011Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,393 Total Patients Enrolled
1 Trials studying Ovarian Cancer
275 Patients Enrolled for Ovarian Cancer
Cancer Research Institute, New York CityOTHER
20 Previous Clinical Trials
1,239 Total Patients Enrolled
3 Trials studying Ovarian Cancer
224 Patients Enrolled for Ovarian Cancer
AstraZenecaIndustry Sponsor
4,266 Previous Clinical Trials
288,605,922 Total Patients Enrolled
47 Trials studying Ovarian Cancer
23,790 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ and bone marrow functions are currently healthy.I have not received a live vaccine in the last 4 weeks.Any side effects from my previous treatments have mostly gone away.I am a woman with ovarian cancer that is not responding to platinum-based chemotherapy.I have received treatments that are not chemotherapy for my condition, excluding those targeted by this study.Patients must have a medical condition that can be measured using a specific method called RECIST 1.1.My heart's electrical cycle is longer than normal, or I take medications that can extend this cycle.My cancer is resistant to platinum treatment and progressed within 6 months after the last chemotherapy.I agree to have biopsies before and during treatment.My cancer has spread to my brain.I will take a pregnancy test if I can have children.I have had immune therapy without severe side effects.It has been at least 4 weeks since my last cancer treatment.It's been over 28 days since my last major surgery and my wounds have healed.I am mostly active and doctors expect me to live for at least 3 more months.It's been over 4 weeks since my last non-cancer treatment before joining.I am 18 years old or older.I have had an autoimmune or inflammatory disorder in the last 3 years.I have agreed to provide a sample of my tumor for research.I had another type of cancer but it was treated and won't affect this study's treatment.I have had multiple treatments for my platinum-sensitive condition.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + BA3011
- Group 2: Durvalumab + BA3021
- Group 3: Sub Study X (etc.)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participant numbers in this medical experiment?
"Affirmative. Clinicaltrials.gov supplies evidence that this clinical trial, which first went online on October 12th 2021, is currently seeking participants. Sixty individuals are needed from 6 separate sites to complete the study."
Answered by AI
What prior trials have utilized To be determined as an experimental treatment?
"Currently, 333 studies are being conducted to research To be determined. Of those active trials, 52 have reached Phase 3 status. Most of the inquiry around this treatment is taking place in Cordoba, Texas but there are 12937 additional sites dedicated to researching it as well."
Answered by AI
Are there any available openings for individuals to join this medical trial experiment?
"Confirmed. According to clinicaltrials.gov, this research project launched on October 12th 2021 and is actively seeking participants. As of now, 60 volunteers are needed for the experiment at 6 separate sites."
Answered by AI
Are there any Canadian healthcare facilities that have adopted this trial?
"This trial is available in 6 different sites, situated in Kingston, Vancouver and Kelowna alongside 3 other locales. Prospective participants should select the clinic nearest them to reduce transportation demands."
Answered by AI
What clinical conditions can To be determined typically alleviate?
"An unoperable stage three non-small cell lung cancer, an untreated metastatic ureteral carcinoma, and a yet to be determined treatment can all be addressed with the same therapy."
Answered by AI
Has the To be determined drug been approved by the FDA?
"Our assessment of the safety of To be determined is a 2, given that there are some available data points attesting to its security but no evidence for efficacy yet."
Answered by AI
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