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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.
Must not have
Patients must not have been administered a live vaccine ≤ 4 weeks before enrollment.
QTc (using the Fridericia correction calculation) >470 msec or >450 msec if history of additional risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not received a live vaccine in the last 4 weeks.
Select...
My heart's electrical cycle is longer than normal, or I take medications that can extend this cycle.
Select...
My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
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%
Arthralgia
7%
Hypothyroidism
7%
Haematuria
7%
Abdominal pain
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Pneumonia
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Sub Study X (etc.)Experimental Treatment1 Intervention
Group II: Durvalumab + BA3021 (Arm Closed)Experimental Treatment2 Interventions
Group III: Durvalumab + BA3011 (Arm Closed)Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,807 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
4,397 Previous Clinical Trials
289,121,597 Total Patients Enrolled
46 Trials studying Ovarian Cancer
23,611 Patients Enrolled for Ovarian Cancer

Media Library

BA3011 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04918186 — Phase 2
Ovarian Cancer Research Study Groups: Durvalumab + BA3011 (Arm Closed), Durvalumab + BA3021 (Arm Closed), Sub Study X (etc.)
Ovarian Cancer Clinical Trial 2023: BA3011 Highlights & Side Effects. Trial Name: NCT04918186 — Phase 2
BA3011 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04918186 — Phase 2
~2 spots leftby Dec 2024
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