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Alkylating Agent

Carboplatin for Ovarian Cancer (UPGRADE Trial)

Phase 1

Waitlist Available

Research Sponsored by Mersana Therapeutics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks for the first 12 months, then every 12 weeks on treatment

Awards & highlights

UPGRADE Trial Summary

This trial tests the safety of a new antibody-drug conjugate (XMT-1536) for ovarian cancer. The trial has two parts: a dose escalation portion to find a safe dose, and an expansion portion to study how well the drug works.

Eligible Conditions

Platinum-Sensitive Ovarian Cancer

UPGRADE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks for the first 12 months, then every 12 weeks on treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks for the first 12 months, then every 12 weeks on treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks for the first 12 months, then every 12 weeks on treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

DES: Maximum tolerated dose (MTD) for Upifitamab Rilsodotin with carboplatin

EXP: Assess the feasibility of Upifitamab rilsodotin combination initiated at MTD or RP2D

Secondary outcome measures

DES and EXP: Anti-neoplastic effects of XMT-1536 (Upifitamab rilsodotin) in combination with carboplatin

DES and EXP: Anti-neoplastic effects of XMT-1536 (Upifitamab rilsodotin) in combination with carboplatin PFS (by RECIST 1.1)

DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin)

+6 more

UPGRADE Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion - Module A (UPGRADE-A)Experimental Treatment2 Interventions

Once the MTD or RP2D is achieved in dose escalation, a new group of patients will receive XMT-1536 (Upifitamab Rilsodotin) at this fixed-dose + carboplatin.

Group II: Dose Escalation - Module A (UPGRADE-A)Experimental Treatment2 Interventions

XMT-1536 (Upifitabmab Rilsodotin) + carboplatin is administered in groups of patients who will receive doses of XMT-1536 that increase over time.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PSI CROIndustry Sponsor

6 Previous Clinical Trials

2,227 Total Patients Enrolled

Mersana TherapeuticsLead Sponsor

8 Previous Clinical Trials

1,257 Total Patients Enrolled

2 Trials studying Ovarian Cancer

350 Patients Enrolled for Ovarian Cancer

IQVIA BiotechIndustry Sponsor

19 Previous Clinical Trials

5,377 Total Patients Enrolled

1 Trials studying Ovarian Cancer

31 Patients Enrolled for Ovarian Cancer

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04907968 — Phase 1

Ovarian Cancer Research Study Groups: Dose Escalation - Module A (UPGRADE-A), Dose Expansion - Module A (UPGRADE-A)

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04907968 — Phase 1

Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907968 — Phase 1

Frequently Asked Questions

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

Where are the different places this trial is running?

"Presently, this clinical trial is looking for participants from 12 different sites. Some of these locations include Tucson, Columbus and Burlington. To reduce travel difficulties, it is best to select the site that is closest to your location."

Answered by AI

Is there previous research to support the use of Carboplatin?

"Carboplatin was first trialed in 2002 at the H Central de Asturias medical facility. In the ensuing years, there have been 833 completed clinical trials worldwide. As of right now, 727 different carboplatin trials are actively recruiting patients; a large number of these studies are based in Tucson, Arizona."

Answered by AI

How is Carboplatin most commonly employed in medical treatment?

"Carboplatin is most often used to treat non-hodgkin lymphoma. This chemotherapy can also be effective in treating advanced sarcoma, hodgkin disease, and certain cases of newly diagnosed cancer."

Answered by AI

Are patients currently being enrolled in this trial?

"That is correct. By visiting clinicaltrials.gov, one can see that this trial was posted on 6/11/2021 and is still actively looking for participants. The study will have 48 patients total across 12 locations."

Answered by AI

How many participants will this study have in total?

"Yes, as of 8/30/2022 this study is still recruiting participants. The trial was initially posted on 6/11/2021 and requires 48 patients from 12 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer

2021. "Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04907968.