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Vaccines

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Nivolumab

Poly ICLC

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Immunologic Factors

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Immune Checkpoint Inhibitors

Interferons

Nivolumab at a dose of 240 mg administered by intravenous (IV) infusion over 30 minutes every two weeks. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with nivolumab.

NEO-PV-01

Adjuvant

Mark DeMario, MD

The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer. The study also will investigate if NEO-PV-01 + adjuvant with nivolumab may represent a substantial improvement over other available therapies such as nivolumab alone. All eligible patients will receive NEO-PV-01 + adjuvant and nivolumab while on this trial.

This clinical trial will enroll patients with metastatic or advanced melanoma, lung, or bladder cancer. The three agents being used in this study are:

* A new, investigational, personal cancer vaccine called "NEO-PV-01"
* Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system
* A cancer drug called nivolumab (OPDIVO®)

These agents are considered immunotherapy and work by stimulating the immune system to fight cancer. NEO-PV-01 is a truly personal vaccine therapy in that it is custom designed and manufactured to include targets for the immune system that are present uniquely on an individual's cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01 more effective. Nivolumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack the tumor. Nivolumab is in clinical development for treatment of bladder cancer and is approved by the FDA (the U.S. Food and Drug Administration) for the treatment of some lung, skin, kidney, and blood cancers.

The purpose of this study is to find out if treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and effective for patients with melanoma, lung, or bladder cancer. The study also will see if NEO-PV-01 vaccine + adjuvant with nivolumab can improve responses compared to available therapies such as nivolumab monotherapy The side effects of NEO-PV-01 + adjuvant and nivolumab will be monitored and additional research tests will be done to assess the immune response against each individual's cancer.

A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer

An Open-label, Phase IB Study of NEO-PV-01 + Adjuvant With Nivolumab in Patients With Melanoma, Non-Small Cell Lung Carcinoma or Transitional Cell Carcinoma of the Bladder

Antigen-specificity in peripheral CD8+ and CD4+ T cell responses and tumor biopsies following treatment with NEO-PV-01 + adjuvant and nivolumab

Rate of adverse events including SAEs and AEs leading to treatment discontinuation

Rate of adverse events including SAEs and AEs leading to changes in safety laboratory evaluations

Rate of adverse events including SAEs and AEs leading to physical examination findings

Rate of adverse events including SAEs and AEs leading to vital signs findings

Rate of adverse events including SAEs and AEs leading to changes in ECOG status

Objective response rate (ORR), defined as the proportion of patients who achieve complete response (CR) or partial response (PR) based on Response Criteria in Solid Tumors (RECIST) v1.1.

Duration of response (DOR), defined as the date of the first documentation of a confirmed response to the date of the first documented PD.

Clinical benefit rate (CBR), defined as the proportion of patients who achieve CR, PR, or stable disease (SD) based on RECIST v1.1

Response conversion rate (RCR) of NEO-PV-01 + adjuvant with nivolumab at Week 24 defined as the proportion of patients who improve in RECIST v1.1 category from Week 12 to Week 24 (e.g., PD to SD/PR/CR, SD to PR/CR, PR to CR).

Progression-free survival (PFS), defined as the time from the date of first dosing to the date of first documented PD or death.

Overall survival (OS), defined from the date of enrollment and death from any cause.

Bristol-Myers Squibb

BioNTech US Inc.

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Carboplatin

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Pembrolizumab at a dose of 200 mg administered by intravenous infusion (IV) plus chemotherapy with carboplatin (AUC 5) + pemetrexed (500 mg/m2) every 3 weeks for 4 cycles. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks) while continuing therapy with pembrolizumab.

The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial.

This clinical trial will enroll patients with advanced or metastatic nonsquamous non-small cell lung carcinoma not having received treatment for metastatic disease. The five agents being used in this study are:

* A new, investigational, personalized cancer vaccine called "NEO-PV-01"
* Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system
* A cancer drug called pembrolizumab (KEYTRUDA®)
* A chemotherapy called pemetrexed (ALIMPTA®)
* A chemotherapy called carboplatin

Both NEO-PV-01 and pembrolizumab are considered immunotherapies and work using the immune system to fight cancer. NEO-PV-01 is a custom made vaccine for you that is based on the specific targets on your cancer. Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01, more effective.

Pembrolizumab helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack your cancer. Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, including the type of cancer that you have. Recently, the FDA also approved the combination of Pembrolizumab with chemotherapy for the treatment of your type of lung cancer. This combination works better than each of the drugs on their own.

The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your immune response compared with pembrolizumab and chemotherapy treatment alone. The side effects of NEO-PV-01, pembrolizumab, and chemotherapy will be monitored and additional research tests will be done to assess your immune response to your cancer.

A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer

An Open-Label, Phase 1B Study of NEO-PV-01 With Pembrolizumab Plus Chemotherapy in Patients With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

Antigen-specificity in peripheral CD8+ and CD4+ T cell responses following treatment with NEO-PV-01, pembrolizumab, and chemotherapy.

Analysis of tumor biopsies following treatment of NEO-PV-01, pembrolizumab, and chemotherapy

To determine the anti-tumor activity, as assessed by ORR by iRECIST

To determine the anti-tumor activity, as assessed by PFS by iRECIST

Rate of adverse events and severe adverse events leading to treatment discontinuation and those adverse events and severe adverse events detected during symptom-directed physical examinations (changes in safety laboratory evaluations, physical examination findings. vital signs, and ECOG PS)

Objective Response Rate (ORR), defined as the proportion of patients who achieve complete response (CR) or partial response (PR) based on Response Criteria in Solid Tumors (RECIST) v1.1

Clinical Benefit Rate (CBR), defined as the proportion of patients who achieve a CR, PR, or stable disease (SD) based on RECIST v1.1

Duration of Response, DOR, defined as the date of the first documentation of a confirmed response to the date of the first documented PD based on RECIST v1.1

Response Conversion Rate (RCR), defined as the proportion of patients who improve in RECIST v1.1 category subsequent to vaccination (eg. PD to SD/PR/CR, SD to PR/CR, PR/CR).

Progression Free Survival (PFS), defined as the time from the date of first dosing to the date of first documented PD or death

Overall Survival (OS), defined from the date of enrollment and death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer	NCT02897765	Urinary Bladder... Bladder Tumors Transitional Ce... Malignant Melan... Melanoma Skin Cancer Carcinoma, Non-... Lung Cancer	NEO-PV-01 Nivolumab Adjuvant	18 Years -	BioNTech SE
A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer	NCT03380871	Carcinoma, Non-... Lung Cancer Nonsquamous Non...	NEO-PV-01 Pembrolizumab Adjuvant Carboplatin Pemetrexed	18 Years -	BioNTech SE

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