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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
Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease
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.)
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
Pivotal Trial

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 below
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I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.
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My cancer is one of the specified types of epithelial cell cancer.
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I've had successful surgery to remove as much of the tumor as possible.
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My liver is functioning well, with normal bilirubin and enzyme levels.
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My kidney function is normal, with creatinine levels not exceeding 1.5 times the upper limit.
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My cancer is one of the specified types of advanced epithelial carcinoma.
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My blood tests show enough neutrophils, platelets, and hemoglobin.
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I am set for surgery after 3 treatments with paclitaxel and carboplatin, and will continue treatment post-surgery.
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I will have surgery and start specific chemotherapy for my cancer within 6 weeks after.
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I've had successful surgery to remove as much of my tumor as possible.
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I am 18 years old or older.
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I am 18 years old or older.
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I am fully active or can carry out light work.

FLORA-5 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomization up until date of death from any cause, up to approximately 11 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization up until date of death from any cause, up to approximately 11 years for reporting.

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 • NCT01959672
55%
Leukopenia
36%
Thrombocytopenia
36%
Lymphopenia
18%
Anemia
18%
Reduced ANC
18%
ALT elevation
18%
AST elevation
9%
Orthostasis
9%
Rash
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)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
70,311 Total Patients Enrolled
49 Trials studying Ovarian Cancer
7,232 Patients Enrolled for Ovarian Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04498117 — Phase 3
Ovarian Cancer Research Study Groups: Cohort 2 - NACT + Interval Surgery Control, Cohort 2 - NACT + Interval Surgery Active, Cohort 1- Surgery Active, Cohort 1 - Primary Surgery Control
Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04498117 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04498117 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does Oregovomab compare in risk to other treatments?

"Oregovomab's safety has been supported by data from earlier phases of research as well as multiple rounds of additional studies, so it received a score of 3."

Answered by AI

What is the efficacy of Oregovomab in clinical trials?

"City of Hope Comprehensive Cancer Center first began studying oregovomab in 1997. Out of the 19,753 completed clinical trials, 1,230 are ongoing. Many of these live trials are based in Bedford, Texas."

Answered by AI

At how many hospitals is this type of treatment being tested?

"There are many enrolling sites for this trial, including Texas Oncology DFWW in Bedford, Texas, Honor Health in Phoenix, Arizona, and Park Nicollet Frauenshuh Cancer Center in Saint Louis Park, Minnesota."

Answered by AI

Are there any patients that this research is still looking to enroll?

"That is accurate, the clinicaltrials.gov website highlights that this trial is currently looking for enrollees. This trial was initially posted on August 25th 2020 and was edited November 4th 2020. The study is seeking 602 individuals from 100 locations."

Answered by AI

Why is Oregovomab used by patients?

"Multiple different types of cancer, including melanoma, neoplasm metastasis, and lymphoma, non-hodgkin, can all be treated with the use of Oregovomab."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
65+
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
~181 spots leftby Sep 2025