NCT03590210

Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

NiTraSarc Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas - The NiTraSarc Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The "NiTraSarc" trial evaluates the efficacy and feasibility (as determined by the safety and tolerability) of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas

Detailed description

Undoubtedly, there is a strong medical need for new efficacious therapies for patients with advanced soft tissue sarcomas. While immune oncology treatment approaches like inhibition of immune checkpoints by administration of anti PD-1 / PD-L1 antibodies displayed very promising clinical activity in several types of tumors, current data points out to only limited activity of mono-agent immunotherapy in soft tissue sarcomas (especially in leiomyosarcomas) - although this type of tumor demonstrably displays a certain grade of immunogenicity. That means, STS patients are currently not able to benefit from the advancements in cancer immunotherapy which led to remarkable improvements in outcome in some other tumor entities in the last few years. Interestingly, most recent data indicates that trabectedin could enhance the activity of immune-modulating agents via its influence on the tumor micro-environment and the reduction of tumor associated macrophages. Furthermore, first clinical data obtained from a feasibility study on combined nivolumab/trabectedin therapy in STS patients did not report on significant toxicities when combining the two agents, thereby justifying combination of nivolumab and trabectedin utilizing standard dosages. Therefore, this phase II study will examine if combination of nivolumab with trabectedin is feasible (safe and well tolerated) and efficacious by utilizing potential synergistic effects of both agents. In the long run, the results of this phase II trial could build the basis for further evaluation of the efficacy of the trabectedin / nivolumab combination in a randomized clinical trial involving larger patient numbers. Finally, this could render patients with STS accessible to immunotherapeutics - a promising new class of drugs for anti-cancer treatment.

Conditions

• Metastatic Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin	Cycle 1 to 16 1.5mg/m² IV over 24 hours, q3w
DRUG	Nivolumab	Cycle 2 to 16 240 mg IV over 30 minutes, q3w

Timeline

• Start date: 2018-06-08
• Primary completion: 2022-02-12
• Completion: 2022-02-12
• First posted: 2018-07-18
• Last updated: 2022-11-08

Locations

9 sites across 1 country: Germany