Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Pembrolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Intra-tumoral administration once weekly for the first three weeks of Cycle 1 (Days 1, 8 and 15) and then on Day 1 of Cycles 2 and 3.

IMSA101

1st infusion on Cycle 1 Day 2, and then thereafter as per product label.

Immune checkpoint inhibitor

PULSAR

Patrick Widhelm

Jenny P Sanchez

Kat Irenze, RN

Percy Lee, MD

Sarah Chevalier, RN

Andrew Zeng

Jason Ye, MD

Talia Oughourlian

Drew Moghanaki, MD

Elise Catherine Lemp

Devalingam Mahalingam, MB BCh, BAO, PhD

Caitlyn Kwan

Mai Anh Huynh, MD

Jennifer Traber

Greg Vlacich, MD

Adel Zakharia

Alla Ahmed

Nitin Ohri, MD

Megan Tyler

Aryavarta Kumar, MD

Ahmed Gul

Sarah Neufelf

Mona Arbab, MD

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior anti-cancer therapy.

Patients shall be enrolled in 2 treatment arms as follows:

1. 15 patients in the control arm (PULSAR-ICI alone)
2. 30 patients in the experimental arm (PULSAR-ICI + IMSA101)

PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.

The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.

All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.

All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).

Tumor types and the corresponding treatment combinations to be evaluated will be identified prior to the first patient enrolled.

All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.

Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

Occurrence of treatment-related adverse events and SAEs

Progression-free at 8-week intervals from 6 months to 22 months

Overall response rate, duration of response, progression-free survival

ImmuneSensor Therapeutics Inc.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Fibrinolytic Agents

Anticoagulants

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Durvalumab

Immunoglobulins

Complement System Proteins

Immunoglobulins, Intravenous

Protein C

SAbR with each radiation treatment fraction delivered every other day

PULSAR with each radiation treatment fraction delivered every 4 weeks

Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.

Stereotactic radiation therapy

Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.

Vanessa Igbeka

Sarah Neufeld, MS, MBA

Sarah Neufeld, MS

Shahed Badiyan, MD

This is a randomized Phase II study which is designed to determine the impact of stereotactic radiotherapy and durvalumab on quality-of-life and oncologic outcomes in patients with advanced non-small cell lung cancer. Durvalumab (Imfinzi) and stereotactic radiotherapy, with each fraction of radiotherapy is given every other day on a standard stereotactic ablative radiotherapy (SAbR) schedule or every four weeks on the personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) schedule. Subjects will be followed for a period of 2 years after completion of treatment or until death, whichever occurs first. Specifically, subjects will be followed at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months following treatment. After the 2 year follow up, the patient can continue routine follow up with their physicians, per standard of care. Subjects removed from therapy for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

We hypothesize that Durvalumab and stereotactic radiotherapy, in the form of PULSAR and SAbR, and durvalumab will confer a 60% increase in improvement in quality of life over the historical control rate of 33%, for an absolute improvement of 27%. Using a two-sided exact binomial test with a two-sided significance level of 0.1 and 80% power, we estimate that we will need to enroll 23 patients per arm do detect a difference. Accounting for 10% attrition, we will plan to enroll 52 patients.

Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC

Randomized Phase II Study of Durvalumab (MEDI 4736) and Stereotactic Radiotherapy for Advanced Non-Small Cell Lung Cancer

To assess the impact of durvalumab and stereotactic radiotherapy, in the form of stereotactic ablative radiotherapy (SAbR) or personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR), on improving QoL (quality of life) in patients with metastatic non-small cell lung cancer using the European organization for Research and treatment of cancer questionnaire (EORTC-QLQ30). The score range is 0-100. Higher the score, the better the results.

To determine the effect of PULSAR or SAbR plus durvalumab on local control. Local control is defined as the percentage of tumors without tumor failure within the irradiated field, as defined as growth on diagnostic imaging studies or evidence of viable cancer cells. Probability will be assessed using the Kaplan-Meier method.

To assess the effect of PULSAR or SAbR plus durvalumab on out-of-field control (termed abscopal response). Out-of-field control is defined as the percentage of tumors without tumor failure outside of the irradiated field, as defined as growth on diagnostic imaging studies or evidence of viable cancer cells. Probability will be assessed using the Kaplan-Meier method.

To determine the effect of PULSAR or SAbR plus durvalumab on progression-free survival. Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause. Probability will be assessed using the Kaplan-Meier method.

To determine the effect of PULSAR or SAbR plus durvalumab on overall survival. Overall survival (OS) is defined as the defined as the time between the date of randomization and the date of death due to any cause. Probability will be assessed using the Kaplan-Meier method.

To determine the effect of PULSAR or SAbR plus durvalumab on overall response rate at 12 weeks. Overall response rate is defined as complete response and partial response at 12 weeks (about 3 months) from randomization.

To determine the effect of PULSAR or SAbR plus durvalumab on toxicity. Toxicity will be assessed using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Only adverse events assessed to be definitely, probably, or possibly related to protocol treatment will be considered.

University of Texas Southwestern Medical Center

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Renal Cell

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

1st infusion on Cycle 1 Day 2, and then thereafter as per product label

Juan Miranda

Maggie Thomas, RN, BSN

Krishna Reddy, MD

Manideepika Katta

Matthew Deek, MD

Alena Turner

Benjamin Maughan, MD, Pharm D

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with NSCLC or RCC

Patients shall be enrolled in 2 treatment arms as follows:

1. 20 patients in the control arm (PULSAR-ICI alone)
2. 20 patients in the experimental arm (PULSAR-ICI + IMSA101)

Patients will be stratified by histology (NSCLC and RCC) in the randomized portion.

PULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.

The study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.

All patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.

All patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).

All patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.

Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC

Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligometastatic NSCLC and RCC

Occurrence of treatment-related adverse events

Patient reported outcome on FACT-G questionnaire

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Recurrence

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Disease Attributes

Pancreatic Cancer

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Toripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs.

Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.

Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.

PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times.

PD-1

Nab-paclitaxel, 125mg/m2，IV，D1，8, Q3W

Nab-paclitaxel

Gemcitabine，1000mg/m2，IV，D1，8，Q3W

Si Shi, PHD

Weijing Zhang

This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.

This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.

Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), surgical conversion rate, and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery. This is a single-center study. A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled.

The estimated enrollment time is 18 months, with at least 18 months of follow-up for each subject.

This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis. The National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE version 5.0) were used. The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records.

PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients

A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.

PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.

ORR is defined as the percentage of subjects with complete response (CR) or partial response (PR) by investigator assessment per RECIST criteria, version 1.1.

OS is defined as the time from the date of randomization to the date of death due to any cause.

The surgery is scheduled to take place after a minimum of 4 weeks from the last dose to allow the effects of the drug to wear off. The eligible subjects can undergo surgery within 8 weeks from the last dose. A successful resection is achieved when a patient achieves R0 or R1 resection. However, if a patient has R2 resection or unresectable, then it is considered as resection failure. The pathology committee of our center determines the surgical results of R0, R1, and R2 based on the tissue obtained during the operation.

Fudan University

Professor

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Fractionated stereotactic radiotherapy (fSRT) will be delivered to all previously untreated brain metastases noted at the time of treatment (up to 10 max). All brain metastases will be treated concurrently, 3 fractions total, delivered every other day (\~2 times/week) with first cycle of Durvalumab.

Personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR), will be delivered to all previously untreated brain metastases noted at the time of treatment (up to 10 max). All brain metastases will be treated concurrently, 3 "pulses" of radiation total, delivered one pulse monthly with each cycle of Durvalumab.

24-27 Gy in 3 fractions- one plan, given once every other day with first cycle of Durvalumab for comparator arm. 24-27 Gy in 3 "pulses"- each pulse of radiation re-planned, given once every 4 weeks with each Durvalumab for experimental arm.

Stereotactic Radiation Therapy

Sarah Neufeld

Kiran Kumar, MD

This is a research study to find out if the new anti-cancer drug Durvalumab combined with radiation therapy to the brain will work in treating brain metastases from non-small cell lung cancer (NSCLC). Focused, highly precise radiation therapy to the brain, known as stereotactic radiosurgery (SRS), is a standard of care treatment that is commonly used for patients with metastatic lung cancer to the brain. It is standardly used as an alternative to surgery to eradicate the targeted tumours in the brain and prevent them from growing and causing symptoms. This study will look at the combination of the novel immunotherapy Durvalumab with two different ways of delivering SRS: 1) with each radiation treatment given every other day for 3 treatments with the first dose of Durvalumab (fSRT), or 2) with each radiation treatment, referred to as a "pulse," given every 4 weeks with each dose of Durvalumab for 3 treatments (PULSAR).

Based on investigator's hypothesis of improved rate of intracranial clinical benefit at 6-months from historical control of 60% to 86% and 10% attrition rate, a sample size of 23 patients is needed per study arm (total N=46) using a two-sided exact binomial test with a two-sided α=0.1 and power=80%.

Durvalumab (MEDI4736) and Radiosurgery (fSRT vs. PULSAR) for the Treatment of Non-Small Cell Lung Cancer Brain Metastases

A Phase II Clinical Trial of Durvalumab (MEDI4736) and Fractionated Stereotactic Radiotherapy (fSRT) vs. Personalized Ultra-Fractionated Stereotactic Adaptive Radiotherapy (PULSAR) for the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)

Intracranial clinical benefit (Complete Response, Partial Response, or Stable Disease) assessed per the brain modified (bm) RECIST (response evaluation criteria in solid tumors) criteria

All acute toxicities (CNS and non-CNS) will be evaluated using the NCI Common Terminology Criteria of Adverse Events (CTCAE) version 5.0, with results tabulated to examine frequency, severity, organs affected, and relationship to study treatment.

Functional Assessment of Cancer Therapy brain (FACT-Br) questionnaires. scoring range 0-200. Higher the score, the better the QOL

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies	NCT05846659	Oligoprogressiv...	IMSA101 Immune checkpoi... PULSAR	18 Years -	ImmuneSensor Therapeutics Inc.
Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC	NCT04786093	Non Small Cell ...	Stereotactic ra... Durvalumab	18 Years -	University of Texas Southwestern Medical Center
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC	NCT05846646	Oligometastatic...	IMSA101 Immune checkpoi... PULSAR	18 Years -	ImmuneSensor Therapeutics Inc.
PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients	NCT06359275	Pancreatic Canc...	PD-1 Nab-paclitaxel Gemcitabine PULSAR	18 Years - 75 Years	Fudan University
Durvalumab (MEDI4736) and Radiosurgery (fSRT vs. PULSAR) for the Treatment of Non-Small Cell Lung Cancer Brain Metastases	NCT04889066	Brain Metastase...	Stereotactic Ra... Durvalumab	18 Years -	University of Texas Southwestern Medical Center
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies	NCT05846659	Oligoprogressiv...	IMSA101 Immune checkpoi... PULSAR	18 Years -	ImmuneSensor Therapeutics Inc.

Spots Global Cancer Trial Database for pulsar

Every month we try and update this database with for pulsar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pulsar

Every month we try and update this database with for pulsar cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pulsar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.