Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Treatment will consist of IT administrations of BO-112 in combination with ablative radiotherapy (SABR) and concurrent with systemic administration of nivolumab in patients with metastatic PD-1/PD-L1-refractory NSCLC.

In the initial cohort A, BO-112 will be IT injected on a weekly basis during the first cycle on the accessible lesions, and every 2 weeks thereafter. The minimum dose to be injected per visit is 1 mg (unless injected lesion in case of response, if solitary, becomes smaller than 1.5 cm) and the maximum dose is 2 mg (3.4 mL), distributed in the different lesions.

Stereotactic ablative radiotherapy (SABR) will be initiated on week 3.

In the cohort B, BO-112 and SABR will be administered as described previously.

Nivolumab will be administered at the dose of 240 mg every 2 weeks in both cohorts, starting at cycle 4 (week 7) in cohort A and at cycle 3 (week 5) in cohort B.

Study treatment will consist of BO-112 IT injections in combination with IV nivolumab infusions and SABR to accessible metastases.

BO-112 in combination with ablative radiotherapy (SABR) and nivolumab

Four research biopsies will be taken from accessible injected lesions, at the time of the IT injection of BO-112.

Tissue Biopsies

María E Rodríguez Ruiz

María E Rodríguez, MD

Maria E Rodriguez, PhD

This is a study of repeated IT administrations of BO-112 in combination with ablative radiotherapy (SABR) and concurrent nivolumab in patients with metastatic PD-1/PD-L1-refractory NSCLC.

This is a phase Ib/II study to evaluate feasibility-efficacy of repeated IT administrations of BO-112 in combination with ablative radiotherapy (SABR) and concurrent with systemic administration of nivolumab in patients with metastatic PD-1/PD-L1-refractory NSCLC.

To be eligible, all patients must have metastatic NSCLC with at least one accessible lesion amenable to IT BO-112 injection and radiotherapy administration. The study will include an initial cohort A using a standard "3+3" design to determine the safety profile of SABR in combination with BO-112 and nivolumab, which will start on cycle 4 (week 7) and a cohort B, with the same combination but with nivolumab starting on cycle 3 (week 5).

In the initial cohort A, BO-112 will be IT injected on a weekly basis during the first cycle on the accessible lesions, and every 2 weeks thereafter. On the liver, the maximum frequency for IT injection will be every 2 weeks since the first administration. After the first cycle, BO-112 will continue to be IT injected every 2 weeks on the previously treated lesions provide they are still injectable. A maximum of 2 hepatic lesions will be treated with BO-112 at each cycle and a maximum of 5 multisite tumoral lesion in total. The minimum dose to be injected per visit is 1 mg (unless injected lesion in case of response, if solitary, becomes smaller than 1.5 cm) and the maximum dose is 2 mg (3.4 mL), distributed in the different lesions. Distribution of volume of injection will be determined based on the size of lesion to be injected. Stereotactic ablative radiotherapy (SABR) will be initiated on week 3. Patients will be evaluated for DLTs until 28 days after the first dose of nivolumab.

In cohort B, BO-112 and SABR will be administered as described previously.

Nivolumab will be administered at the dose of 240 mg every 2 weeks in both cohorts, starting at cycle 4 (week 7) in cohort A and at cycle 3 (week 5) in cohort B.

This is a phase Ib/II study with one single treatment arm (BO-112 in combination with SABR and nivolumab)

Study of BO-112 With Radiotherapy and Nivolumab for Metastatic Refractory NSCLC

Phase Ib/II Open-label Clinical Study of Intratumoral Administration of BO-112 in Combination With Radiotherapy and Nivolumab in Patients With Metastatic PD- 1/PD-L1 Refractory Non-small Cell Lung Cancer

Number and proportion of subjects with TEAEs with severity ≥ Grade 3 (NCI-CTCAE v. 5.0)

Number and proportion of subjects with study treatment-related TEAEs Grade ≥3, number and proportion of subjects with TEAEs (any grade); number and proportion of subjects with related TEAEs (any grade).

t Time from C1D1 to the first occurrence of disease progression or death from any cause

ORR based on the best overall response (BOR); disease control rate (DCR = CR, PR and SD of at least 12 weeks duration) on the global tumor assessment in ITT population.

* DCR = iCR, iPR + iSD of at least 12 weeks duration) in ITT population.
* Overall survival rate at 12 months.

Number of study discontinuations due to related TEAE.

Highlight Therapeutics

Clinica Universidad de Navarra, Universidad de Navarra

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphosarcoma

Dermatologic Agents

Coal Tar

Patients with cancer or benign tumors being treated on NCI/DTC studies

Jennifer H Zlott

Alice P Chen, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These include blood draws and biopsies. Researchers collect data from these samples. Some people take part in more than one study at the DTC. At this time, data are connected only with one single study. Researchers want to access people s medical records. This will allow them to link the research data from all their studies they have or will take part in. Researchers also want to collect medical data about their diagnosis and treatment history. This will allow them to see how their cancer reacted to different drugs over time.

Objective:

To enter people into a master protocol to connect research sample and treatment data across DTC studies.

Eligibility:

People ages 18 and older who are being evaluated or treated for cancer in the DTC

Design:

Participants will allow researchers to look at all the data from their research samples. This includes those from their current, past, and any future NIH studies.

Participants will allow researchers to access some of their medical data. This includes age, diagnosis, treatment history, and response to treatment.

Participants will provide no new samples.

...

Background:

Research samples and data collected on a treatment-intent protocol are discrete items associated with that protocol up until the patient comes off study, usually due to disease progression. These data are not stored in the patient s medical records, but are essential to understand tumor response to different drugs over time. Patients in the Developmental Therapeutics Clinic (DTC) often start other clinical trials; this protocol provides a mechanism to connect research data about that patient from one trial to the next as long as the patient remains eligible and has given his or her informed consent. No new analysis will be performed under this protocol.

There is research interest in collecting pre- and post-dose research biopsies and other samples such as circulating tumor cells to measure dynamic drug-specific target effects (e.g., changes in epithelial-mesenchymal transition, DNA damage response, or immunotherapeutic cell infiltration), and then to evaluate molecular changes before and during disease progression to understand why the tumors initially respond but then became resistant to treatment.

To accomplish this, we will connect research results from consecutive trials with limited patient information (age, gender, disease, prior therapies, protocol number/drug regimen, response, and duration of treatment).

Each patient who consents to participate in this non-treatment, longitudinal sample protocol agrees to allow his or her Medical Record Number (MRN) to be used to track participation on DTC clinical trials.

Objectives:

Patients will be entered onto this "master" longitudinal protocol to connect research sample and treatment data across consecutive DTC clinical trials.

Biopsy samples collected at time of disease progression on one research trial will be evaluated for use as the baseline sample for the next research trial, potentially obviating the need for additional biopsies.

Eligibility:

Adult patients who are being evaluated for and/or treated for cancer or benign tumors at the DTC.

Design:

No samples will be collected under this longitudinal protocol, no treatment decisions will be made based on data collected, and no new analysis will be performed.

Specimens for research purposes, as outlined in this protocol, will be those obtained from tests and procedures that are done as required by the primary research protocols that a given patient is enrolled in. Tissue collected under DTC tissue procurement protocol 06-C-0213 will not be used or tracked.

Sample location and use will be managed in the Repository at the Frederick National Laboratory for Cancer Research using LabMatrix software.

Patients may remain on this longitudinal protocol for the duration of their consent.

Sample Collection and Tracking for the Developmental Therapeutics Clinic

Longitudinal Sample Collection and Tracking for the Developmental Therapeutics Clinic, National Cancer Institute

Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials

National Cancer Institute (NCI)

Symptoms and General Pathology

Heart and Blood Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Marrow Diseases

Tissue samples will be collected for research purposes from non-surgical procedures, such percutaneous biopsies for the sole purpose of obtaining specimens or biological fluids for the protocol.

Biopsy

Nancy Moore, R.N.

James H Doroshow, M.D.

Kathryn S Sutton, MD

Anna Maria Storniolo, MD

Stephanie Chen, MD

Nyall London, M.D. PHD

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Ryan C. Fields, MD

John Kane, MD

Jim Rocco, MD, PhD

Kyle VanKoevering, MD

Rakesh Sindhi, MD

Kelly Smith, MD PhD

Background:

-Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.

Objectives:

* To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.
* To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.

Eligibility:

-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center participating sites.

Design:

* This is a multicenter tissue procurement protocol with NCI as the coordinating center.
* For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
* For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
* Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.
* This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.
* Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

Background:

Patients who are being evaluated and/or treated at the NIH Clinical Center and at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.

Objectives:

To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.

To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.

Eligibility:

Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center and at participating sites.

Design:

This is a multicenter tissue procurement protocol with NCI as the coordinating center.

For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed on adult patients at the NIH Clinical Center for the sole purpose of obtaining tissue specimens or biological fluids. Tissues and biological fluids to be procured may include blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.

For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.

Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.

This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate samples for ongoing research on assay development and studies of molecular pathways; and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate samples to create preclinical models.

Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

Collection of Tissue Samples for Cancer Research

Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

Delinking of patient samples for research

Anticoagulants

Other Dietary Supplements

Citric Acid

Sodium Citrate

Citrate

additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.

tissue biopsies

additional blood samples will be collected during a SOC sampling procedure (2 EDTA 7.5 ml tubes, 2 SST 7.5 ml tubes and 2 citrate 5 ml tubes)

blood sampling

constitutional and somatic genetic alterations will be analysed for subjects who consent, from either tumor or healthy tissue, or whole blood buffy coat after centrifugation

DNA banking

Alexis CORTOT, MD,PhD

Eric WASIELEWSKI, M

Alexis Cortot, MD,PhD

This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.

Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.

serum, plasma, tumor tissue, healthy tissue, stools (gut microbiome)

A Clinico-biological Database of Lung Cancers

This mesure evaluate subject's emotional skills in regard of the clinical trial inclusion process between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)

This mesure evaluate between baseline and first disease assessment (T1), first occurence of progression (T2), second occurence of progression (T3)

Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (partial response defined as a decrease of at least 30% in size of target lesions, complete response defined as a disappearance of all lesions)

Assessment of tumor response to SOC treatment, using RECIST 1.1 criteria (disease progression defined as an increasement of at least 20 % in size of target lesions, and/or appearance of new lesions)

length (in days) and grade of the treatment-related toxicities, using Common Terminology Criteria for Adverse Events version 4

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of BO-112 With Radiotherapy and Nivolumab for Metastatic Refractory NSCLC	NCT05265650	Non-Small Cell ...	BO-112 in combi... Tissue Biopsies	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra
Sample Collection and Tracking for the Developmental Therapeutics Clinic	NCT03269578	Neoplasms Lymphoma		18 Years -	National Institutes of Health Clinical Center (CC)
Collection of Tissue Samples for Cancer Research	NCT00900198	Neoplasms Lymphomas Multiple Myelom... Myelodysplastic...	Biopsy	2 Months -	National Institutes of Health Clinical Center (CC)
A Clinico-biological Database of Lung Cancers	NCT03387865	Lung Cancer	tissue biopsies blood sampling DNA banking	-	University Hospital, Lille

Spots Global Cancer Trial Database for tissue biopsies