Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
The FDA has granted Fast Track designation to Pasithea Therapeutics' PAS-004 for treating NF1-associated plexiform neurofibromas. The designation facilitates expedited development and review for serious conditions with unmet medical needs. Pasithea is currently conducting Phase 1/1b trials of the next-generation MEK inhibitor in patients with these tumors.
Immunotherapy is increasingly used in earlier cancer stages before or after surgery across seven tumor areas. Research shows neoadjuvant and adjuvant immunotherapy can reduce recurrence risk and improve immune recognition of tumor cells. However, challenges remain including side effects, costs, and determining which patients benefit most from earlier treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07540468 |
Safety Evaluation of Bioactive Glass Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors |
NOT_YET_RECRUITING | NA |
| NCT07475312 |
SUPPORT+ Digital Self-Management and Clinical Support for Advanced Cancer |
ACTIVE_NOT_RECRUITING | NA |
| NCT07432295 |
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2) |
RECRUITING | PHASE2 |
| NCT07428278 |
Resilience-Building for Advance Care Planning |
NOT_YET_RECRUITING | NA |
| NCT07426757 |
An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers |
NOT_YET_RECRUITING | PHASE1 |
| NCT07408310 |
Trial of Spiritual Care Interventions for Patients With Cancer |
NOT_YET_RECRUITING | NA |
| NCT07393529 |
A Pilot Randomized Controlled Trial of a Social Network Intervention |
RECRUITING | NA |
| NCT07382544 |
Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss |
RECRUITING | PHASE1 |
| NCT07367984 |
A Feasibility Study of Death Education Intervention for Family Caregivers of Advanced Cancer Patients |
NOT_YET_RECRUITING | NA |
| NCT07364305 |
HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC |
RECRUITING | PHASE2 |
