NCT02842125

Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer

Terminated Phase 1, PHASE2 Last updated 2 June 2020

What this trial tests

Phase 1, PHASE2 trial testing Ad-P53 in Metastatic Solid Tumor Cancer in 4 participants. Terminated before completion.

Timeline

20 November 2018

Primary endpoint
8 May 2020

8 May 2020

Quick facts

Lead sponsor	MultiVir, Inc.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	20 November 2018
Primary completion	8 May 2020
Estimated completion	8 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Ad-P53 — full drug profile →
• Xeloda (capecitabine) — full drug profile →
• Keytruda (pembrolizumab) — full drug profile →
• Opdivo (nivolumab) — full drug profile →

Conditions studied

• Metastatic Solid Tumor Cancer — all drugs for Metastatic Solid Tumor Cancer →
• Recurrent Head and Neck Cancer — all drugs for Recurrent Head and Neck Cancer →

Sponsor

MultiVir, Inc. — full company profile →

Who can join

18 and older, any sex, with Metastatic Solid Tumor Cancer or Recurrent Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1/2 study of the combination of Ad-p53 administered intra-arterially in combination with oral metronomic capecitabine or pembrolizumab in patients with unresectable, refractory liver metastases of colorectal carcinoma (CRC) and other solid tumors, including primary hepatocellular carcinoma (HCC). A third arm will study the intra-tumoral injection of Ad-p53 combined with nivolumab infusions in recurrent head and neck squamous cell cancer (HNSCC). This safety study has a standard 3+3 design for arms A and B; .HNSCC will be placed in a single dosing cohort. The Maximum Tolerated Dose (MTD) will be determined as well for intra-arterial infusions, and the entire study will determine the general efficacy using RECIST 1.1 and Immune-Related Response Criteria. Safety will be followed using the CTCAE listings for adverse events.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of tumor mutation burden as an immunotherapy biomarker: utility for the oncology clinic.
   Chan TA, Yarchoan M, Jaffee E, Swanton C, et al · · 2019 · cited 2009× · PMID 30395155 · DOI 10.1093/annonc/mdy495
2. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
3. The Role of p53 Signaling in Colorectal Cancer.
   Liebl MC, Hofmann TG. · · 2021 · cited 231× · PMID 33924934 · DOI 10.3390/cancers13092125
4. Combining Oncolytic Viruses With Cancer Immunotherapy: Establishing a New Generation of Cancer Treatment.
   Shi T, Song X, Wang Y, Liu F, et al · · 2020 · cited 134× · PMID 32411132 · DOI 10.3389/fimmu.2020.00683
5. Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
   Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295
6. Improved Nucleic Acid Therapy with Advanced Nanoscale Biotechnology.
   Weng Y, Huang Q, Li C, Yang Y, et al · · 2020 · cited 72× · PMID 31927331 · DOI 10.1016/j.omtn.2019.12.004
7. Immunology of Adenoviral Vectors in Cancer Therapy.
   Shaw AR, Suzuki M. · · 2019 · cited 62× · PMID 31890734 · DOI 10.1016/j.omtm.2019.11.001
8. Combination Immunotherapy Using Oncolytic Virus for the Treatment of Advanced Solid Tumors.
   Oh CM, Chon HJ, Kim C. · · 2020 · cited 50× · PMID 33086754 · DOI 10.3390/ijms21207743