TABLE 3.

Clinical trials utilizing multiplex immunohistochemistry and other spatial imaging technologies.

Adoption of spatially resolved multiplexing technologies in pivotal clinical trials, suggesting a role for spatial signatures as both prognostic and predictive indicators for therapeutic benefit ⁹² . Over the next 3–5 years, transition from small exploratory studies to large scale registrational studies is anticipated.

Trial id	Responsible parties	Tech provider	Phase/Trial type	Description
NCT01042379 a	QuantumLeap Healthcare Collaborative, University of California San Francisco	Akoya	Ph2, Retrospective	Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY: Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
NCT02785250 b	IMV Inc	Akoya	Ph1b/2, Retrospective	Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
NCT04688658 c	Bristol Myers-Squibb, Secura Bio Inc	Akoya	Ph1/2, Prospective	Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma
NCT04963283 d	National Cancer Institute, Criterium Inc., Bristol Myers-Squibb, Exelixis	Akoya	Ph2, Prospective	Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer
NCT00114816 e	Finnish Breast Cancer Group, Hoffmann-La Roche, Sanofi, AstraZeneca	Nanostring	Ph3, Retrospective	Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer (FinXX)
NCT04895761 f	Providence Health and Services	Nanostring	Ph1b, Prospective	Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+ HER2- Breast Cancer
NCT04622423 g	IRCCS San Raffaele, Università Vita-Salute San Raffaele	10X Genomics	Ph?, Prospective	Advanced Therapies for Liver Metastases (LiMeT)
NCT05371756 h	Baylor Research Institute	10X Genomics	Ph?, Prospective	Collection of Patients’ Biospecimens for Analysis of Immunological and Molecular Biomarkers (TIOB)
NCT03299946 i	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Bristol Myers-Squibb, Exelixis	Standard BioTools	Ph1b, Retrospective	Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)
NCT03669601 j	Cambridge University Hospitals NHS Foundation Trust, AstraZeneca	Standard BioTools	Ph1, Retrospective	AZD6738 and Gemcitabine as Combination Therapy (ATRiUM)
NCT04009967 k	CHU de Quebec-Universite Laval, Merck Sharp & Dohme LLC.	Standard BioTools	Ph2, Prospective	Biomarkers for Neoadjuvant Pembrolizumab in Non-Metastatic Prostate Cancer Positive by 18FDG-PET Scanning (PICT-01)
NCT04393285 l	Gynecologic Oncology Group Foundation, Eli Lilly and Company	Standard BioTools	Ph2, Prospective	Abemaciclib and Letrozole to Treat Endometrial Cancer
NCT04951154 m	Janssen Research and Development LLC.	Standard BioTools	Ph?, Prospective	A Study to Examine Biomarkers From Lung and Blood Samples in Participants With Suspected Lung Cancer
NCT04053673 n	Ribon Therapeutics Inc	IonPath	Ph1, Retrospective	Phase 1 Study of RBN-2397, an Oral PARP7 Inhibitor, in Patients With Solid Tumors
NCT04068194 o	National Cancer Institute	IonPath	Ph1/2, Prospective	Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
NCT02528357 p	GlaxoSmithKline, Merck Sharp & Dohme LLC.	Leica	Ph1, Retrospective	GSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)
NCT03506373 q	National Cancer Institute, Mayo Clinic	Leica	Ph2, Prospective	Ibrutinib and Ixazomib Citrate in Treating Patients With Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia
NCT05163041 r	BicycleTx Limited	Leica	Ph1/2, Prospective	Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression
NCT03291002 s	CureVac, Syneos Health, Cromos Pharma LLC.	Nanostring/Leica	Ph1, Retrospective	Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC

Assumptions and Notes

^a https://clinicaltrials.gov/ct2/show/NCT01042379

^b https://clinicaltrials.gov/ct2/show/NCT02785250

^c https://clinicaltrials.gov/ct2/show/NCT04688658

^d https://clinicaltrials.gov/ct2/show/NCT04963283

^e https://clinicaltrials.gov/ct2/show/NCT00114816

^f https://clinicaltrials.gov/ct2/show/NCT04895761

^g https://clinicaltrials.gov/ct2/show/NCT04622423

^h https://clinicaltrials.gov/ct2/show/NCT05371756

ⁱ https://clinicaltrials.gov/ct2/show/NCT03299946

^j https://clinicaltrials.gov/ct2/show/NCT03669601

^k https://clinicaltrials.gov/ct2/show/NCT04009967

^l https://clinicaltrials.gov/ct2/show/NCT04393285

^m https://clinicaltrials.gov/ct2/show/NCT04951154

ⁿ https://clinicaltrials.gov/ct2/show/NCT04053673

^o https://clinicaltrials.gov/ct2/show/NCT04068194

^p https://clinicaltrials.gov/ct2/show/NCT02528357

^q https://clinicaltrials.gov/ct2/show/NCT03506373

^r https://clinicaltrials.gov/ct2/show/NCT05163041

^s https://clinicaltrials.gov/ct2/show/NCT03291002