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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

Must not have

Contraindications to the use of pressor agents

Anticipated treatment with any other anti-cancer medications, including bevacizumab, PARP inhibitors, or any investigational agent(s) during the study

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

Summary

This trial tests if oregovomab, an IV medication, can help treat advanced ovarian cancer when used with standard chemotherapy. It targets patients who have had surgery to remove tumors and aims to boost the immune system to fight cancer cells more effectively. Oregovomab has been previously tested in advanced ovarian cancer but did not improve outcomes.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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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.

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I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.

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I've had successful surgery to remove as much of the tumor as possible.

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My cancer is one of the specified types of advanced epithelial carcinoma.

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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 am 18 years old or older.

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I've had successful surgery to remove as much of my tumor as possible.

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My kidney function is normal, with creatinine levels not exceeding 1.5 times the upper limit.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take medications that raise blood pressure.

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I am not planning to take any other cancer treatments during the study.

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I have a history of brain issues, uncontrolled seizures, or brain cancer spread.

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My cancer is a specific type like mucinous adenocarcinoma or has neuroendocrine features.

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I've had specific chemotherapy treatments before surgery for my cancer.

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I do not have any serious infections right now.

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I have had multiple surgeries to remove cancer or haven't recovered from one.

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I have had a heart attack in the last 6 months or currently have severe heart issues.

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I am currently being treated for an active autoimmune disease.

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I have a known immune system disorder.

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I am on long-term medication that suppresses my immune system.

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I do not have any severe diseases that could risk my safety in the study.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigator Assessed Progression Free Survival

Secondary study objectives

Change in Quality of Life

Overall Survival

Safety and Tolerability

Other study objectives

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

Orthostasis

Rash

Pancreatitis

Nausea

Vomiting

Dehydration

Depression

Somnolence

Hypokalemia

Hyperkalemia

Pneumonia

Acidosis

Urinary tract infection

Sepsis

Pleural effusion

Sinusitis

Cardiac disorders

100%

80%

60%

40%

20%

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.

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

~5450

Carboplatin

2014

Completed Phase 3

~6120