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Angiogenesis Inhibitor

Combination Chemotherapy + Immunotherapy for Ovarian Cancer

Phase 1

Waitlist Available

Research Sponsored by Tesaro, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has histologically or cytologically proven advanced (unresectable) or metastatic cancer

Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28.5 months

Awards & highlights

Study Summary

This trial is testing the safety and tolerability of different combinations of drugs to treat ovarian cancer. The drugs being tested are Niraparib, TSR-042, Carboplatin-Paclitaxel, Bevacizumab, Carboplatin-Pemetrexed, and Carboplatin-nab-Paclitaxel. The trial will help establish a safe dose for each combination of drugs that will be used in future studies.

Who is the study for?

This trial is for adults with advanced or metastatic cancer, specifically non-small cell lung cancer. They must have measurable lesions, be able to take oral medications (for certain parts), and have proper organ function. Women of childbearing potential need a negative pregnancy test and agree to contraception; men must also agree to use contraception. Exclusions include prior treatments targeting immune checkpoints, active infections like HIV or hepatitis B/C, autoimmune diseases requiring treatment within the past 2 years, known hypersensitivities to study drugs, and other specific medical conditions.Check my eligibility

What is being tested?

The trial is testing various combinations of chemotherapy drugs (Carboplatin-Pemetrexed/Paclitaxel/Nab-Paclitaxel) with Niraparib (a PARP inhibitor), TSR-042 (an anti-PD-1 therapy), Bevacizumab (anti-cancer drug), and TSR-022 (another immunotherapy agent). The goal is to determine safe doses for future Phase 2 studies by assessing safety and tolerability in different combination therapies across multiple parts of the study.See study design

What are the potential side effects?

Potential side effects may include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, allergic reactions related to infusion processes or drug components. Specific side effects depend on the drug combination received but can affect organs such as the liver or kidneys.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced and cannot be removed by surgery.

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I can carry out all my usual activities without help.

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I can take medications by mouth.

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I weigh at least 77 kg and my platelet count is over 150,000.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Number of Participants With Dose-limiting Toxicity (DLT)

Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)

Part B: Number of Participants With DLT

+15 more

Secondary outcome measures

Part A: AUC at Steady State (AUCss) of Niraparib

Quibron T-SR

Part A: AUC(0-t) of TSR-042

+211 more

Trial Design

11Treatment groups

Experimental Treatment

Group I: Part I: TSR-042, TSR-022, and carboplatin-paclitaxelExperimental Treatment3 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days).

Group II: Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxelExperimental Treatment3 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.

Group III: Part G: TSR-042 and carboplatin-nab-paclitaxelExperimental Treatment2 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.

Group IV: Part F: TSR-042, TSR-022, and carboplatin-pemetrexedExperimental Treatment3 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for 5 cycles (each cycle is 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).

Group V: Part E: TSR-042 and carboplatin-pemetrexedExperimental Treatment2 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for 6 cycles (each cycle is 21 days).

Group VI: Part D: TSR-042, carboplatin-paclitaxel and bevacizumabExperimental Treatment3 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.

Group VII: Part C: TSR-042, niraparib 300 mg QD and bevacizumabExperimental Treatment3 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.

Group VIII: Part C: TSR-042, niraparib 200 mg QD and bevacizumabExperimental Treatment3 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.

Group IX: Part B: TSR-042 and carboplatin-paclitaxelExperimental Treatment2 Interventions

Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.

Group X: Part A: TSR-042 and niraparib 300 mg QDExperimental Treatment2 Interventions

Group XI: Part A: TSR-042 and niraparib 200 mg QDExperimental Treatment2 Interventions

Patients will receive TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~1540

Bevacizumab

2013

Completed Phase 4

~5280

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor

56 Previous Clinical Trials

10,498 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,872 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03307785 — Phase 1

Frequently Asked Questions

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

How is the combination of Carboplatin-Nab-Paclitaxel typically employed?

"Carboplatin-Nab-Paclitaxel is a commonly employed medication to treat malignant neoplasms, but can also be beneficial for patients with advanced nonsquamous non-small cell lung cancer, metastatic colorectal cancer (CRC), and diseases that have worsened after platinum chemotherapy."

Answered by AI

What is the overarching intent of this research?

"The primary endpoint for this clinical trial, monitored over 21 days, is the number of participants with DLT. Secondary objectives include measuring AUC0-t levels of TSR-042 and TSR-022 through blood sample testing at designated time points."

Answered by AI

What is the current participant count for this experiment?

"Unfortunately, no further recruitment is being done for this particular trial. The original posting was on October 12th 2017 with the last update occuring in October 31st 2022. If you are still looking to take part in a study, there are currently 5037 investigations recruiting patients affected by carcinoma and 1597 trials searching for volunteers who have been administered Carboplatin-Nab-Paclitaxel."

Answered by AI

Has the combination of Carboplatin-Nab-Paclitaxel been sanctioned by the Food & Drug Administration?

"Our risk assessment of Carboplatin-Nab-Paclitaxel scores a 1, as this is an early phase trial that has not yet provided sufficient evidence to support safety and efficacy."

Answered by AI

Are the enrollment criteria currently being fulfilled for this experiment?

"This clinical trial has ceased recruitment of participants, with its initial post dating back to October 12th 2017 and last edit occurring on October 31st 2022. For those who are still searching for studies, there are currently 5037 active trials recruiting patients with carcinoma, non-small-cell lung cancer as well as 1597 Carboplatin-Nab-Paclitaxel related experiments that need volunteers."

Answered by AI

Are there any other venues besides this site where the experiment is being conducted within our state?

"Currently, 8 clinics across the United States - including Cleveland, Nashville and Houston - are enrolling participants in this trial. To reduce travel strain, it is recommended to pick a clinic close by if you decide to join the study."

Answered by AI

Can you provide an overview of the prior investigations utilizing Carboplatin-Nab-Paclitaxel?

"In 1997, the City of Hope Comprehensive Cancer Center first conducted research into Carboplatin-Nab-Paclitaxel. There have been 2576 investigations completed since then and currently there are 1597 ongoing studies, many being carried out in Cleveland, Tennessee."

Answered by AI