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Alkylating agents
Oregovomab + Chemo for Advanced Ovarian Cancer (FLORA-5 Trial)
Phase 3
Waitlist Available
Research Sponsored by OncoQuest Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.)
Adequate liver function: Bilirubin < 1.5 times upper limit normal (ULN), Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of randomization up until date of death from any cause, up to approximately 11 years
Awards & highlights
FLORA-5 Trial Summary
This trial is testing a new drug for ovarian cancer that may be more effective and have fewer side effects than current treatments.
Who is the study for?
This trial is for adults over 18 with newly diagnosed advanced ovarian, fallopian tube, or peritoneal cancer who've had successful debulking surgery. They must have certain types of epithelial adenocarcinoma and be willing to avoid pregnancy. Exclusions include those with BRCA mutations intending to use PARP inhibitors, allergies to trial drugs, autoimmune diseases, uncontrolled illnesses, other recent cancers or treatments that might interfere.Check my eligibility
What is being tested?
The study tests the effectiveness of oregovomab versus a placebo when given alongside standard chemotherapy (paclitaxel and carboplatin) in patients after optimal debulking surgery for advanced ovarian cancer. The goal is to compare safety and efficacy outcomes between the two groups.See study design
What are the potential side effects?
Possible side effects may include allergic reactions due to murine proteins in oregovomab; typical chemo-related issues like nausea, fatigue, hair loss; blood count changes leading to increased infection risk; organ function problems related to liver or kidneys from drug toxicity.
FLORA-5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is one of the specified types of epithelial cell cancer.
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My liver is functioning well, with normal bilirubin and enzyme levels.
Select...
I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.
Select...
I've had successful surgery to remove as much of the tumor as possible.
Select...
My cancer is one of the specified types of advanced epithelial carcinoma.
Select...
I am set for surgery after 3 treatments with paclitaxel and carboplatin, and will continue treatment post-surgery.
Select...
I will have surgery and start specific chemotherapy for my cancer within 6 weeks after.
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I am 18 years old or older.
Select...
I've had successful surgery to remove as much of my tumor as possible.
Select...
My kidney function is normal, with creatinine levels not exceeding 1.5 times the upper limit.
Select...
I am fully active or can carry out light work.
FLORA-5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of randomization up until date of death from any cause, up to approximately 11 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomization up until date of death from any cause, up to approximately 11 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator Assessed Progression Free Survival
Secondary outcome measures
Change in Quality of Life
Overall Survival
Safety and Tolerability
Other outcome measures
Efficacy by times to subsequent therapies and time to next progression
Potential Biomarkers
Side effects data
From 2018 Phase 2 trial • 11 Patients • NCT0195967255%
Leukopenia
36%
Thrombocytopenia
36%
Lymphopenia
18%
Anemia
18%
Reduced ANC
18%
ALT elevation
18%
AST elevation
9%
Rash
9%
Orthostasis
9%
Pancreatitis
9%
Nausea
9%
Vomiting
9%
Dehydration
9%
Depression
9%
Somnolence
9%
Hypokalemia
9%
Hyperkalemia
9%
Pneumonia
9%
Acidosis
9%
Urinary tract infection
9%
Sepsis
9%
Pleural effusion
9%
Sinusitis
9%
Cardiac disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
FLORA-5 Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2 - NACT + Interval Surgery ActiveExperimental Treatment3 Interventions
In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
Group II: Cohort 1- Surgery ActiveExperimental Treatment3 Interventions
Six (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
Group III: Cohort 2 - NACT + Interval Surgery ControlPlacebo Group3 Interventions
In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).
Group IV: Cohort 1 - Primary Surgery ControlPlacebo Group3 Interventions
Six (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Oregovomab
2013
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
OncoQuest Pharmaceuticals Inc.Lead Sponsor
3 Previous Clinical Trials
74 Total Patients Enrolled
1 Trials studying Ovarian Cancer
10 Patients Enrolled for Ovarian Cancer
CanariaBio Inc.Lead Sponsor
5 Previous Clinical Trials
218 Total Patients Enrolled
2 Trials studying Ovarian Cancer
98 Patients Enrolled for Ovarian Cancer
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
70,771 Total Patients Enrolled
49 Trials studying Ovarian Cancer
7,692 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take medications that raise blood pressure.I am not planning to take any other cancer treatments during the study.I have a history of brain issues, uncontrolled seizures, or brain cancer spread.My cancer is a specific type like mucinous adenocarcinoma or has neuroendocrine features.My cancer is one of the specified types of epithelial cell cancer.I've had specific chemotherapy treatments before surgery for my cancer.You are allergic to murine proteins or any of the ingredients in oregovomab, paclitaxel, or carboplatin.My cancer has a specific genetic feature but I won't receive a certain type of gene-targeting therapy as the first treatment.I do not have any serious infections right now.I have had multiple surgeries to remove cancer or haven't recovered from one.I have had a heart attack in the last 6 months or currently have severe heart issues.I haven't had any live vaccines in the last 4 weeks and won't during or for 3 months after the study.I am 18 years old or older.My liver is functioning well, with normal bilirubin and enzyme levels.You have HIV, hepatitis B, or hepatitis C, and your viral load is not under control with medication or treatment.I don't have any serious health or mental conditions that could stop me from completing the treatment.I am currently being treated for an active autoimmune disease.I have a known immune system disorder.I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.I've had successful surgery to remove as much of the tumor as possible.I have a BRCA1 or BRCA2 mutation, or my test results were unclear.I am on long-term medication that suppresses my immune system.My cancer is one of the specified types of advanced epithelial carcinoma.My blood tests show enough neutrophils, platelets, and hemoglobin.I am set for surgery after 3 treatments with paclitaxel and carboplatin, and will continue treatment post-surgery.I haven't had cancer, except for certain skin cancers or treated early-stage cancers, in the last 5 years.I have been on corticosteroids for more than 5 days, not counting inhalers or planned tapering.I will have surgery and start specific chemotherapy for my cancer within 6 weeks after.I am not pregnant, breastfeeding, or have tested positive for pregnancy recently.I do not have any severe diseases that could risk my safety in the study.I am 18 years old or older.I've had successful surgery to remove as much of my tumor as possible.Your blood test shows high levels of CA-125 before surgery or before starting certain chemotherapy.My kidney function is normal, with creatinine levels not exceeding 1.5 times the upper limit.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 - NACT + Interval Surgery Control
- Group 2: Cohort 2 - NACT + Interval Surgery Active
- Group 3: Cohort 1- Surgery Active
- Group 4: Cohort 1 - Primary Surgery Control
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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