BridgeMD
New treatment option for Ovarian Cancer
Official title Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
ClinicalTrials.gov ID: NCT04918186
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- This study will enroll women with platinum resistant high grade serous ovarian cancer.
- This study is open to minorities as appropriate but is not designed to measure differences in intervention effects.
- All patients must be registered for screening prior to study enrollment, however, if biomarker testing results are not required prior to enrollment...
- Patients must have platinum resistant high grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within 6...
- All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
You likely can't join if
- Patients with a history of other malignancy may be eligible if curatively treated and/or the malignancy does not affect the determination of safety...
- Patients with uncontrolled or serious illnesses, or medical conditions which could cause unacceptable safety risks or would not permit the patient to...
- history of intra-abdominal abscess within 3 months prior to starting treatment;
- other active infection or chronic liver disease requiring systemic therapy;
- active or known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection on antiviral treatment or with detectable viral load;
- history of interstitial lung disease, non-infectious pneumonitis or severe pulmonary disease exacerbated by pneumonitis or uncontrolled diseases...
See the full eligibility criteria
Who can join
- This study will enroll women with platinum resistant high grade serous ovarian cancer.
- This study is open to minorities as appropriate but is not designed to measure differences in intervention effects.
- 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. CCTG will...
- Patients must have platinum resistant high grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within 6 months of last platinum containing chemotherapy. Histological...
- All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
- Chest x-ray ≥ 20 mm
- CT scan (with slice thickness of 5 mm) ≥ 10 mm - longest diameter
- Physical exam (using calipers) ≥ 10 mm
- Lymph nodes by CT scan ≥ 15 mm - measured in short axis
- Patients must have at least one disease site amendable to pre and on-treatment biopsies and must consent to undergo these tumour biopsies.
- Prior surgery is permitted provided that a minimum of at least 28 days have elapsed between any major surgical procedure and date of enrollment, and that wound healing has occurred.
- Systemic Therapy:
- There is no limit to the number of prior regimens for platinum-sensitive disease. However, patients may not have received more than one cytotoxic chemotherapy regimen for platinum-resistant disease.
- Patients may have received non-cytotoxic therapies (excluding agents targeted by the planned substudy). Refer to each substudy protocol for exclusions.
- Prior treatment with an immune checkpoint inhibitor (ICI) is permissible providing the ICI was not discontinued for severe or recurrent severe toxicity (including myocarditis, or other myocardiotoxicity, encephalitis...
- A minimum of 4 weeks must have elapsed between last dose of prior therapy and enrollment.
- All reversible prior toxicity must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity)
- Other Therapy:
- Radiation, endocrine therapy, or other non-anti-cancer investigational agents are permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose and enrollment. Exceptions may be made for low-dose...
- ECOG performance status 0 or 1 and have a life expectancy ≥ 3 months.
- Patients must be ≥ 18 years of age.
- All patients must have consented to:
- Release of tumour block from their primary or metastatic tumour, if available. If archival tissue is unavailable, a tumour biopsy is required during screening. The centre/pathologist must have agreed to the submission...
- Pre and on treatment tumour biopsies:
- Core needle (a minimum of 6 core samples are required) or excisional biopsies or resected tissue specimens are required.
- CCTG will advise sites when biomarker testing results are required prior to enrollment
- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the trial.
- Patients must have adequate organ and marrow function measured within 7 days prior to enrollment including;
- Absolute neutrophils ≥ 1.5 x 10\^9/L (1500/µL)
- Platelets ≥ 100 x 10\^9/L (100 x 103/µL)
- Hemoglobin ≥90g/L\ (10.0 g/dL) with no blood transfusions in the past 28 days.
- Bilirubin ≤ 1.5 x ULN (upper limit of normal)\ \
- AST \& ALT ≤ 2.5 x ULN; if patient has liver metastases ≤ 5.0 x ULN
- Serum creatinine or: Creatinine clearance ≤ 1.5 x ULN / \>50 mL/min
- Albumin \>35 g/L (3.5 g/dL)
- INR/PTT INR \< 1.7 or PTT \< 4 seconds above control
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to...
- Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example...
- Patient must agree to return to their primary care facility for any adverse events, response assessments and follow-up, which may occur through the course of the trial.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment.
- Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation
What rules you out
- Patients with a history of other malignancy may be eligible if curatively treated and/or the malignancy does not affect the determination of safety or how well it works of the investigational regimen (must be confirmed...
- Patients with uncontrolled or serious illnesses, or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol or substudy. This includes but...
- history of intra-abdominal abscess within 3 months prior to starting treatment;
- other active infection or chronic liver disease requiring systemic therapy;
- active or known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection on antiviral treatment or with detectable viral load;
- history of interstitial lung disease, non-infectious pneumonitis or severe pulmonary disease exacerbated by pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.
- clinically significant pleural, pericardial, and/or peritoneal effusion (e.g., effusion affecting normal organ function and/or requiring percutaneous drainage or diuretic control);
- autoimmune disease requiring chronic steroid use;
- prior history of a stroke or transient ischemic attack within the last 6 months;
- history of significant cardiac disease within 6 months prior to starting treatment such as myocardial infarction, unstable angina, cardiomyopathy, congestive heart failure;
- prior allogeneic stem cell transplantation or organ transplantation.
- Central nervous system metastases
- Symptomatic uncontrolled brain metastases requiring corticosteroid treatment.
- History of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting investigational agent(s).
- Pregnant or lactating (breastfeeding) women.
- Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents.
- Active or prior documented autoimmune or inflammatory disorders, including: inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other...
- Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions considered to be of...
- Patients must not have been administered a live vaccine ≤ 4 weeks before enrollment. Note: Seasonal vaccines for influenza are general inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Kelowna, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.