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Checkpoint Inhibitor

DCC-3014 + Avelumab for Sarcomas

Q: Has a similar research effort ever been undertaken before?

<p>EMD Serono Research &#x26; Development Institute, Inc. kickstarted the exploration of DCC-3014 back in 2014 by running a 204 patient trial and subsequently gained approval for Phase 2 clinical trials. As it stands today, there are 111 live studies being conducted worldwide across 1024 cities spread over 52 countries.</p>

Memorial Sloan Kettering Cancer Center, New York, NY

Targeting 7 different conditionsDCC-3014 +1 morePhase 1Waitlist AvailableLed by Sandra D'Angelo, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Dose expansion phase: Patients must have a histologically confirmed metastatic and/or locally undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, or dedifferentiated liposarcoma

Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up1 year

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing a new drug combo to see if it's safe for people with advanced sarcomas.

Eligible Conditions

Sarcoma
Liposarcoma
Leiomyosarcoma
Pleomorphic Sarcoma
Myxofibrosarcoma

Eligibility Criteria

Inclusion Criteria

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

Select...

You have been diagnosed with advanced high-grade sarcoma that has spread to other parts of the body or is locally advanced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose

Overall Response Rate

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

Gastrointestinal disorders

General disorders and administration site conditions

Immune system disorders

Cardiac disorders

Nervous system disorders

Endocrine disorders

Metabolism and nutrition disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Infections and infestations

Investigations

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Advanced High-grade SarcomaExperimental Treatment2 Interventions

Dose Escalation: Up to 18 pts with locally advanced or metastatic high-grade sarcomas Dose Expansion: 10 pts per each diagnosis - undifferentiated pleomorphic sarcoma or myxofibrosarcoma, Leiomyosarcoma, Dedifferentiated liposarcoma

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 3

~3250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,909 Previous Clinical Trials

588,862 Total Patients Enrolled

69 Trials studying Sarcoma

13,582 Patients Enrolled for Sarcoma

ENABLE MEDICINEUNKNOWN

Sandra D'Angelo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

4 Previous Clinical Trials

185 Total Patients Enrolled

3 Trials studying Sarcoma

143 Patients Enrolled for Sarcoma

Media Library

Avelumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04242238 — Phase 1

Sarcoma Research Study Groups: Advanced High-grade Sarcoma

Sarcoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04242238 — Phase 1

Avelumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242238 — Phase 1

Frequently Asked Questions

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

What is the total enrollment capacity for this medical research?

"At present, this trial is not looking for participants. The original posting was on January 22nd 2020 with the last update made in October 26th 2022. If you are curious about other studies focussing on sarcoma and DCC-3014 specifically, there are currently 478 and 111 trials recruiting patients respectively."

Answered by AI

Are new participants being accepted to this research project?

"Unfortunately, this medical trial is not presently enlisting participants. Initially posted on January 22nd 2020 and adjusted as of October 26th 2022 - if you seek other clinical trials, there are 478 studies actively recruiting sarcoma patients and 111 for DCC-3014 looking for volunteers."

Answered by AI

Has DCC-3014 been evaluated in past studies?

"Currently, 111 trials for DCC-3014 are currently in progress, with 10 of them being Phase 3. These studies have been established across 3678 centres; the majority being located in Barcelona and South Dakota."

Answered by AI

Has the FDA officially sanctioned DCC-3014?

"The team at Power gave DCC-3014 a score of 1 due to its Phase 1 status, indicating there is minimal evidence supporting safety and efficacy."

Answered by AI

Has a similar research effort ever been undertaken before?

"EMD Serono Research & Development Institute, Inc. kickstarted the exploration of DCC-3014 back in 2014 by running a 204 patient trial and subsequently gained approval for Phase 2 clinical trials. As it stands today, there are 111 live studies being conducted worldwide across 1024 cities spread over 52 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas

2020. "Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04242238.

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