Rina-S for Ovarian Cancer

(RAINFOL-02 Trial)

Recruiting at 38 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Genmab

Must be taking: Platinum chemotherapy, Bevacizumab, PARP inhibitors, Mirvetuximab

Must not be taking: Topoisomerase inhibitors

Disqualifiers: Platinum-refractory, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 5 years

530 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase 3 study will be conducted in different countries all over the world. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for Rina-S (olaparib) in humans?

Olaparib, also known as Rina-S, has been shown to be generally safe in humans, with common side effects including mild anemia (low red blood cell count), fatigue, vomiting, diarrhea, and nausea. In some cases, more severe side effects like neutropenia (low white blood cell count) and thrombocytopenia (low platelet count) have been observed, especially when combined with other treatments. ^{1 2 3 4 5}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for those with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer who've had platinum-based therapy and are platinum-resistant. They must have positive FRα expression and no contraindications to bevacizumab unless documented. Those treated with PARP inhibitors due to BRCA mutations can join if mirvetuximab soravtansine is available locally.

Inclusion Criteria

I have received bevacizumab for my condition if it was recommended and available.

Participants may be enrolled regardless of FRα expression level

I have BRCA mutation and received a PARP inhibitor after responding to platinum-based chemotherapy.

Exclusion Criteria

I have been treated with a specific drug that targets cancer cells.

My cancer did not respond to initial platinum-based chemotherapy.

I have active brain metastases or carcinomatous meningitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Rina-S or one of four chemotherapy agents as treatment for platinum-resistant ovarian cancer

Up to approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Rina-S

Trial Overview The study compares Rina-S against standard chemotherapy drugs (PLD, Gemcitabine, Paclitaxel, Topotecan) for treating platinum-resistant ovarian cancer. Participants have a 50:50 chance of receiving either Rina-S or one of the chemotherapies without knowing which one until the first dose.

How Is the Trial Designed?

Group I: Rina-S Experimental Treatment 1 Intervention

Group II: Investigator's Choice Active Control 4 Interventions

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Published Research Related to This Trial

Olaparib significantly improves progression-free survival (PFS) in patients with platinum-sensitive BRCA-mutated ovarian cancer, with a hazard ratio of 0.31, indicating a strong benefit compared to placebo or chemotherapy.

The treatment also shows a slight improvement in overall survival (OS) with a hazard ratio of 0.75, while maintaining a manageable safety profile with mostly mild adverse effects like anemia and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of olaparib maintenance therapy in platinum-sensitive ovarian cancer patients with BRCA mutations: a meta-analysis on randomized controlled trials. Ma, J., Deng, H., Li, J., et al.[2020]

In the TRINOVA-1 study involving 919 women with recurrent ovarian cancer, treatment with trebananib plus weekly paclitaxel significantly improved progression-free survival (PFS) compared to placebo, with PFS of 7.2 months versus 5.4 months.

Despite the improvement in PFS, the quality of life (HRQoL) for patients receiving trebananib remained stable, showing negligible changes in HRQoL scores over 25 weeks, indicating that the treatment did not compromise patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Fujiwara, K., Monk, BJ., Lhommé, C., et al.[2020]

In a study of 19 ovarian cancer patients treated with olaparib over a median duration of 12 months, 95% experienced adverse events (AEs), with the most common being fatigue, nausea, and anemia, indicating that while AEs are prevalent, they are often manageable.

The study found that dose modifications for managing AEs were effective, with eight patients requiring dose adjustments and five successfully re-escalating their doses, suggesting that olaparib can be safely administered with careful monitoring and management of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib dose re-escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series. Ngu, SF., Tse, KY., Chu, MMY., et al.[2021]

In women with platinum-sensitive recurrent ovarian cancer, BRCA mutations serve as a key predictive marker for targeted therapy, indicating that those with these mutations are more likely to benefit from PARP inhibitors like olaparib.

For patients without BRCA mutations, bevacizumab is currently the preferred maintenance therapy, emphasizing the importance of genetic screening to tailor treatment strategies and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspective on maintenance therapies for platinum- sensitive recurrent ovarian cancer in women with germline and somatic mutations in BRCA1 and BRCA2 genes. Vergote, I., Bours, V., Blaumeiser, B., et al.[2023]

The combination of olaparib and carboplatin is tolerable and shows clinical benefit in patients with BRCA wild-type high-grade serous ovarian carcinoma, with a clinical benefit rate of 64% in heavily pretreated patients.

The maximum tolerated dose was established at olaparib 400 mg twice daily with carboplatin AUC4, although significant side effects like neutropenia and thrombocytopenia were observed, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/Ib study of olaparib and carboplatin in heavily pretreated recurrent high-grade serous ovarian cancer at low genetic risk. Lampert, EJ., Hays, JL., Kohn, EC., et al.[2023]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of olaparib maintenance therapy in platinum-sensitive ovarian cancer patients with BRCA mutations: a meta-analysis on randomized controlled trials. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Olaparib dose re-escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series. [2021]

4. Belgium pubmed.ncbi.nlm.nih.gov

New perspective on maintenance therapies for platinum- sensitive recurrent ovarian cancer in women with germline and somatic mutations in BRCA1 and BRCA2 genes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I/Ib study of olaparib and carboplatin in heavily pretreated recurrent high-grade serous ovarian cancer at low genetic risk. [2023]