Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (NCT04208958) | Clinical Trial Compass
CompletedPhase 1/2
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
United States56 participantsStarted 2020-01-23
Plain-language summary
This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Partial Inclusion Criteria:
* Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease.
* Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1
* Tumor lesions amenable for biopsy, if deemed safe by the investigator
* Toxicity from prior cancer therapy should have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed)
Partial Exclusion Criteria:
* Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma)
* Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis.
* Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll.
* Patients with known active hepatitis (e.g., hepatitis B …
What they're measuring
1
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Timeframe: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up
2
Objective Response Rate (ORR)
Timeframe: 18 months (first patient enrolled to last patient visit completed)