Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Prostatic Neoplasms

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Cholangiocarcinoma

Uterine Cervical Neoplasms

Melanoma

Vulvar Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Liver Neoplasms

Glioblastoma

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Carcinoma, Transitional Cell

Sarcoma

Brain Neoplasms

Skin Neoplasms

Uterine Neoplasms

Testicular Neoplasms

Laryngeal Diseases

Oligodendroglioma

Neoplasms, Unknown Primary

Adenocarcinoma, Bronchiolo-Alveolar

Colonic Neoplasms

Rectal Neoplasms

Adrenal Gland Neoplasms

Kidney Neoplasms

Urinary Bladder Neoplasms

Adenocarcinoma of Lung

Laryngeal Neoplasms

Bile Duct Neoplasms

Thyroid Neoplasms

Thyroid Carcinoma, Anaplastic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Pancreatic Diseases

Prostatic Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Esophageal Diseases

Stomach Diseases

Rectal Diseases

Uterine Cervical Diseases

Adrenal Gland Diseases

Urinary Bladder Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Otorhinolaryngologic Neoplasms

Otorhinolaryngologic Diseases

Vulvar Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Leah Streuber, BS

Patrick deGrouchy, BA

Ken Dixon, MD

The PIONEER Initiative stands for Precision Insights On N-of-1 Ex vivo Effectiveness Research. The PIONEER Initiative is designed to provide access to functional precision medicine to any cancer patient with any tumor at any medical facility. Tumor tissue is saved at time of biopsy or surgery in multiple formats, including fresh and cryopreserved as a living biospecimen. SpeciCare assists with access to clinical records in order to provide information back to the patient and the patient's clinical care team. The biospecimen tumor tissue is stored in a bio-storage facility and can be shipped anywhere the patient and the clinical team require for further testing. Additionally, the cryopreservation of the biospecimen allows for decisions about testing to be made at a later date. It also facilitates participation in clinical trials. The ability to return research information from this repository back to the patient is the primary end point of the study. The secondary end point is the subjective assessment by the patient and his or her physician as to the potential benefit that this additional information provides over standard of care. Overall the goal of PIONEER is to enable best in class functional precision testing of a patient's tumor tissue to help guide optimal therapy (to date this type of analysis includes organoid drug screening approaches in addition to traditional genomic profiling).

The PIONEER Initiative is a lead clinical trial designed to provide the foundation for subsequent adaptive trials. The mission with this and subsequent trial activity will be to demonstrate the utility of carrying out functional precision medicine in that cohort of patients who receive local cancer care at institutions that do not have significant research capabilities or are not NCI-designated cancer centers. As discussed above, the vast majority of cancer patients (\~85%) are in this category. It is imperative to open up the possibility of best-in-class functional precision medicine testing to these patients. Core aspects of the PIONEER Initiative include recruiting a cadre of up to 200 patients, showing that proof of concept in a more limited set of patients can ultimately scale to arbitrarily large numbers of patients. It is anticipated that PIONEER will continue as the foundation for subsequent clinical trials into the indefinite future. This evolving trial structure fills an important unmet need within the broader cancer community since the primary mission is the return of actionable information in order to positively impact care.

The underlying basic assumption of the PIONEER Initiative is that the ability to receive the best in cancer care should not be restricted as to location, age, or medical condition. The PIONEER Initiative design facilitates inclusion of subjects across all these divides, thus providing beneficence to all participants. A key aspect of the PIONEER Initiative is to provide patient benefit through a data and tissue biorepository to be utilized by researchers to discover new cancer diagnostics, treatment therapies and preventive strategies. Additionally, the data and samples will be used to improve existing treatments and to understand, at the molecular level, changes occurring during transition from illness to remission and/or relapse. SpeciCare, through the PIONEER Initiative, will store de-identified self-reported data, medical records, and biological samples from individuals who consent to participate in PIONEER. PIONEER will obtain further study and testing as appropriate and return results, through CLIA certified labs, through research vetted by CLIA testing, and, as enabled by current regulatory standards, through delivery of research results back to the patient and patient's clinical care team.

SPECIFIC OBJECTIVES

1. To establish a data and tissue biobank comprised of high quality biological specimens and associated clinical data that will support drug discovery, diagnostic assay development, oncology biomarker discovery, molecular biology, immuno-oncology therapies, translational medicine and other future discoveries as novel methods become available.
2. To facilitate and accelerate oncology research, including genetic research (e.g. whole genome sequencing), by providing a pipeline of high quality specimens and associated clinical data for researchers to access.

Biospecimens are saved in fresh and cryopreserved state. Also, FFPE, DNA, and RNA extraction.

The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)

The PIONEER Initiative: Precision Insights On N-of-1 Effectiveness Research. Tissue Ownership by the Individual With the Return of Actionable Information to the Individual Patient and Physician (Precision Oncology)

Data will be shared with strategic partners with appropriate IRB vetting.

Monitor the ability to return research and study information back to the individual patient and cancer care team over time. We will calculate the % of patients that carry out additional genomic testing, % of patients that carry out additional functional precision testing, and % of clinicians that report that they altered their clinical therapeutic regiments based upon these results

Survey of study subjects and physicians as to the benefit or not of access to this additional data in attempting to improve upon standard of care of the day. We will calculate this as a % of patients.

The primary mission of our team is to assess benefit of patient tissue ownership and functional testing to the standard of care process. We will calculate this as a % of patients.

Georgia Institute of Technology

Predictive Oncology

University of Washington

Netnoids

Northeast Georgia Hospital System

SpeciCare

Carcinoma, Non-Small-Cell Lung

Carcinoma, Large Cell

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immunomodulating Agents

Monatide (IMS 3015)

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

Cohort 3: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%

cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI, TPS/TC ≥50% or IC ≥10%

cOBD (TBD) dose IMU-201 as a 05 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level

IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.

IMU-201 (administered as PD1-Vaxx) - Regimen 1

IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.

IMU-201 (administered as PD1-Vaxx) - Regimen 2

IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.

IMU-201 (administered as PD1-Vaxx) - Regimen 3

Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.

Chemotherapy to be administered according to the prescribing information.

Standard of care chemotherapy

An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter).

Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product, IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.

It is hypothesized that a polyclonal induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy.

This phase 1/1b study is an open-label dose escalation/dose expansion study designed to assess the safety, tolerability, immunogenicity and efficacy of IMU-201 (PD1-Vaxx). Phase 1 monotherapy dose-escalation of IMU-201 (PD1-Vaxx), will enroll approximately 9-18 patients and establish the optimal monotherapy biological dose (mBOD). Once established, the dose cohort will be expanded to enroll additional 10 patients at the mBOD dose level. Phase 1b, a combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without chemotherapy, will enroll approximately 18-36 patients and establish the optimal combotherapy biological dose (cBOD). Once established, the dose cohort will be expanded to enroll additional 30 patients at the cBOD dose level.

A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer

An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU-201, a B-Cell Immunotherapy as Monotherapy or in Combination With Atezolizumab With or Without Chemotherapy, in Adults With Non- Small Cell Lung Cancer (IMPrinter)

Humoral immunogenicity evaluated by PD-1 specific antibodies (IgG, IgM).

Cellular immunogenicity evaluated by vaccine-specific cytokine levels as well as analysis of regulatory and effector T and B cells.

Safety and Tolerability Measures include: Frequency of adverse events (AEs) graded per terminology criteria for adverse events (CTCAE) version 5.00.

Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.

Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.

Efficacy of IMU-201 will be evaluated by progression free survival at OBD of IMU-201.

Efficacy of IMU-201 will be evaluated by overall survival at OBD of IMU-201.

Efficacy of IMU-201 will be evaluated by duration of response at OBD of IMU-201.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)	NCT03896958	Cancer, All Typ... Cancer of Liver Cancer of Stoma... Cancer of Head ... Cancer of Rectu... Cancer of Kidne... Cancer of Esoph... Cancer of Colon Cancer Skin Cancer of Cervi... Cancer, Metasta... Cancer of Laryn... Cancer of Neck Cancer of Lung Cancer of Brain... Cancer of Vulva... Cancer of Pancr... Sarcoma GIST Small-cell Lung... Adenocarcinoma ... Cancer of Prost... Cancer, Advance... Adrenal Cancer Testicular Canc... Uterine Cancer Bronchoalveolar... Cancer Unknown ... Glioblastoma Mu... Oligodendroglio... Breast Cancer Renal Cell Carc... Hepatocellular ... Cholangiocarcin... Squamous Cell C... Transitional Ce... Cancer, Other Cancer, Anal Melanoma Cancer, Bile Du... Cancer, Bladder Cancer Cords Vo... Cancers Cell Ne... Cancer Differen... Cancer, Anaplas...		1 Month - 99 Years	SpeciCare
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)	NCT03896958	Cancer, All Typ... Cancer of Liver Cancer of Stoma... Cancer of Head ... Cancer of Rectu... Cancer of Kidne... Cancer of Esoph... Cancer of Colon Cancer Skin Cancer of Cervi... Cancer, Metasta... Cancer of Laryn... Cancer of Neck Cancer of Lung Cancer of Brain... Cancer of Vulva... Cancer of Pancr... Sarcoma GIST Small-cell Lung... Adenocarcinoma ... Cancer of Prost... Cancer, Advance... Adrenal Cancer Testicular Canc... Uterine Cancer Bronchoalveolar... Cancer Unknown ... Glioblastoma Mu... Oligodendroglio... Breast Cancer Renal Cell Carc... Hepatocellular ... Cholangiocarcin... Squamous Cell C... Transitional Ce... Cancer, Other Cancer, Anal Melanoma Cancer, Bile Du... Cancer, Bladder Cancer Cords Vo... Cancers Cell Ne... Cancer Differen... Cancer, Anaplas...		1 Month - 99 Years	SpeciCare
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer	NCT04432207	Non Small Cell ... Non Small Cell ... Non-small Cell ... Squamous Non-sm... Large Cell Carc... Adenocarcinoma ...	IMU-201 (admini... IMU-201 (admini... IMU-201 (admini... Atezolizumab Standard of car...	18 Years -	Imugene Limited

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