NCT06444880
Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
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Record History
All 19 versions: 10 with changes below, 9 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Notable Enrollment reopened
- Enrollment increased: 15 → 40 participants
- Site details revised
- Notable Eligibility criteria expanded, about 38 words
- Publications: details revised at 1 of 1 entry
- Study description expanded, about 2 words
- Notable Enrollment reduced: 40 → 15 participants
- Primary completion moved earlier from Jul 31, 2028 to Jul 31, 2027
- Enrollment closed, study ongoing
- Site details revised
- Minor Site contact updatedv13
- Minor Site contact updatedv12
Show 4 earlier versionsHide 4 earlier versions
- Minor Site contact updatedv9
- Minor Site contact updatedv8
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Nov 29, 2024 to Oct 9, 2024
- Site details revised
- Notable Primary completion date: Jul 31, 2026 to Jul 31, 2028v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Arms and interventions
Stage 1 of study treatment involves being given ubamatamab by itself by vein. The first dose will be given over about 4 hours. Depending on how participants respond, later doses may be given over shorter periods of time (possibly down to 30 minutes per infusion). Participants dose of ubamatamab will be increased from a starting dose on Day 1 to a full dose on Day 15. Participants will receive ubamatamab 1 time every week for the first 4 weeks, then every 3 weeks after that, unless the disease gets worse or intolerable side effects occur. • If the disease gets worse after completing 6 weeks of treatment, participants will move to Stage 2 and receive combination therapy.
Participants in Stage 2 will begin receiving ubamatamab and cemiplimab. * If participants are enrolled directly into Stage 2, but did not have therapy with ubamatamab alone, participants will receive ubamatamab 1 time each week for 4 weeks, before beginning combination therapy. * If participants have already completed Stage 1 and are moving on to Stage 2, participants will begin with combination therapy. During Stage 2, ubamatamab is given by vein over 30 minutes to 4 hours, as described above. Cemiplimab is given by vein over 30 minutes.
Drugs: Ubamatamab, Cemiplimab
Sites
1 site in 1 country
- MD Anderson Cancer CenterHouston, Texas, United States