Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma

Conditions

• Metastatic Soft-tissue Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanzalintinib — DRUG
  Zanzalintinib will be supplied by Exelixis, Inc.
• Ipilimumab — DRUG
  Ipilimumab will be commercially sourced.
• Nivolumab — DRUG
  Nivolumab will be commercially sourced.

Study Details

The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies.

Key Dates

Start date

Jan 5, 2026

Status verified

Jan 2026

Primary completion

Aug 12, 2026

Completion

Jul 31, 2031

Study Design

Enrollment

18 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation Dose Level 1 (starting dose): Zanzalintinib + Nivolumab + Ipilimumab
  Zanzalintinib 40 mg by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
• Experimental: Dose Escalation Dose Level 2: Zanzalintinib + Nivolumab + Ipilimumab
  Zanzalintinib 60 mg by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
• Experimental: Dose Escalation Dose Level -1: Zanzalintinib + Nivolumab + Ipilimumab
  Zanzalintinib 20 mg by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.
• Experimental: Expansion: Zanzalintinib + Nivolumab + Ipilimumab
  Zanzalintinib dose determined in Dose Escalation by mouth once per day is self administered daily, and nivolumab 3 mg/kg intravenously and ipilimumab 1 mg/kg intravenously are administered intravenously every 3 weeks for a total of 4 doses. After completion of the first 4 cycles, ipilimumab is discontinued while nivolumab 480 mg intravenously is continued every 4 weeks in combination with daily zanzalintinib.

Primary Outcome Measure

Occurrence of dose-limiting toxicities (DLTs) [ Time Frame: Through day 42 ]

Central Contacts

• Mia Weiss, M.D.
  314-747-3096
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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