Active — Not RecruitingPhase 2

Amivantamab in Adenoid Cystic Carcinoma

United States21 participantsStarted 2022-08-05

Plain-language summary

The purpose of the study is to determine if treatment with amivantamab will be efficacious in patients with recurrent and metastatic adenoid cystic carcinoma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Pathologically or cytologically confirmed adenoid cystic carcinoma. Non-salivary gland primary sites are allowed.
✓. Recurrent and/or metastatic disease not amenable to other curative intent therapy. Patients must have had evidence of progressive disease by RECIST v1.1 within 6 months of study enrollment.
✓. Presence of measurable disease as defined by RECIST v1.1
✓. Age ≥18 years.
✓. ECOG performance status, see Appendix A).
✓. Patients must have adequate organ and marrow function
✓. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression in the last 4weeks.
✓. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.

Exclusion criteria

✕. History of allergy or intolerance to study drug components.
✕. Prior use of amivantamab.
✕.Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:
✕. Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)
✕. CD4 count \<350 at screening
✕. AIDS-defining opportunistic infection within 6 months of start of screening
✕. Not agreeing to start ART and be on ART\>4 weeks plus having HIV viral load\<400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled).
✕.Other clinically active infectious liver disease.

What they're measuring

Overall Response Rate Measured by RECIST Criteria

Timeframe: 2 years

Trial details

NCT IDNCT05074940

SponsorTrisha Wise-Draper

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-02

Results submitted2026-03-06

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