Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Urinary Bladder Neoplasms

Liver Neoplasms

Carcinoma, Basal Cell

Mesothelioma

Mesothelioma, Malignant

Carcinoma, Merkel Cell

Colorectal Neoplasms

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neoplasms, Squamous Cell

Stomach Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Kidney Diseases

Head and Neck Neoplasms

Esophageal Diseases

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Liver Diseases

Esophageal Cancer

Small Cell Lung Cancer

Renal Cell Carcinoma

Stomach Cancer

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Immunomodulating Agents

Small open pilot (n=10) to refine the intervention and study procedures.

* The study will involve three surveys (one before first infusion, one after, and one six weeks later).
* An educational video regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation or PDF alternative to the video
* Question-prompt list (QPL) -list of suggested questions that participant can choose to raise with the oncology team.

Randomized into Intervention Arm

* The study will involve three surveys (one before first infusion, one after, and one six weeks later).
* An educational video regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation or PDF alternative to the video
* Question-prompt list (QPL) -list of suggested questions that participant can choose to raise with the oncology team.
* Audio Recorded Conversation with oncologist

Randomized into Usual Care Arm

* The "control" group will have three surveys (one before first infusion, one after, and one six weeks later)
* Audio Recorded Conversation with oncologist

The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.

Educational Video and QPL List

Usual Care

Laura A Petrillo, MD

The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer.

The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.

This two-part study will 1) refine and 2) pilot test an intervention to improve participant's and caregiver knowledge and increase communication with the oncology team about immunotherapy.

* The intervention involves watching a video developed to educate patients regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation.
* In Part 1 of this study, investigators will conduct a small open pilot to refine the intervention and study procedures.
* In Part 2, investigators will conduct a single-site pilot randomized controlled trial including 130 patients and their caregivers, to evaluate the feasibility of intervention delivery, and the preliminary efficacy of the intervention in improving patient and caregiver knowledge.

Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled

80% of participants randomized to the intervention watch the video and review the QPL.

The primary outcome is participant knowledge, as measured by the Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (minimum score = 0, maximum score =9). The investigators will compute the total knowledge score at baseline and 72 hours.

The primary outcome is participant knowledge, Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (Minimum score = 0, maximum score = 9). The investigators will compute the total knowledge score at baseline and 6 weeks.

The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 72 hours. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80).

The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 6 weeks. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80)

The number of questions asked by patients and caregivers will be assessed by coding the transcripts of audio-recorded oncology visits and compared between arms using the negative binomial model.

Conquer Cancer Foundation

Massachusetts General Hospital

Physician, Division of Palliative Care

subcutaneous injections of IMP321 every 14 days for three months (6 injections. Doses tested: 50, 250, 1,250, 6,250 or 30,000 µg

IMP321

Bernard Escudier, M.D

Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting

This is a single-center, single-arm, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting. After a screening period, patients will enter a drug administration period, followed by a 'post-study' period.

Four IMP321 dose levels, 50 µg, 250 µg, 1.250 mg, 6.250 mg and 30 mg will be evaluated in successive cohorts of patients. At any given dose level 3 patients will be administered one subcutaneous dose every 2 weeks for a total of 12 weeks (6 injections in total), separated by 13-day administration-free intervals.

The next (higher) dose level will be dosed to 3 new patients if the previous dose level has been well tolerated. Investigator will decide whether the safety is acceptable by performing an evaluation after the third administration (at week 8) and if the next patients can be included.

The successive cohorts of patients are summarized as follows:

* Cohort A will correspond to a group of 3 patients receiving the 50 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort B will correspond to a group of 3 patients receiving the 250 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort C will correspond to a group of 3 patients receiving the 1,250 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort D will correspond to a group of 3 patients receiving the 1,250 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort E will correspond to a group of 3 patients receiving the 6,250 µg dose. The patients will receive their first administration one-by-one with a two-weeks interval. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration for the last patient, the following cohort will be undertaken.
* Cohort F will correspond to a group of 3 patients receiving the 6,250 µg dose. If the tolerability of this dose level has been judged acceptable in cohort E, the three patients will receive their first IMP321 injection simultaneously.
* Cohort G will correspond to a group of 3 patients receiving the 30,000 µg dose. The patients will receive their first IMP321 administration one-by-one with a two-weeks interval (+/- 5 days). If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration for the last patient, the following cohort will be undertaken.
* Cohort H will correspond to a group of 3 patients receiving the 30,000 µg dose. If the tolerability of this dose level has been judged acceptable in cohort E, the three patients will receive their first IMP321 injection simultaneously.

Once the main period of study has been completed, namely two weeks after a cohort is completed, i.e. at week 14, all patients will undergo an ambulatory 'post-study' examination.

Patients of the Cohort B, C, E, F and G will participate in a pharmacokinetic (PK) study and all patients in a pharmacodynamic (PD) study involving additional blood samples.

IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)

IMP321 Phase 1 Study in Advanced or Metastatic Renal Cell Carcinoma Patients (P003)

Umanis

Immutep S.A.S.

F. Triebel, Chief Medical Officer

Vaccines

Allogeneic DCs and Autologous RCC Tumor Derived Cells

The primary purpose of this study is to determine the safety of injections prepared from donor blood cells fused to a patient's own tumor cells which are then used to treat advanced (Stage IV) kidney cancer (renal cell carcinoma or RCC). The study will also explore the effect the injections have on the size of the tumor and the response in the patient's immune system following administration.

Approximately 30,000 new cases of kidney cancer will be diagnosed in the U.S. in 2002, with renal cell carcinoma (RCC) being the most commonly diagnosed type. For patients with locally advanced or metastatic disease, the treatment options are extremely limited and additional options are warranted. Although RCC is generally considered resistant to chemotherapy, spontaneous regressions in patients with metastatic disease have led to research involving immune-mediated therapeutic approaches. Clinical responses have been observed and additional immune-modulating therapeutics are being studied.

Several such approaches have used dendritic cells (DCs), which are known to be potent antigen presenting cells. An antigen is a protein that, when shown to the immune system in the right way, can trigger the cells of the immune system to recognize, remember and eliminate other cells that also display that specific antigen. The cancerous cells in tumors present antigens in such a way that the body's immune system often fails to recognize and eliminate them. It is theorized that when DCs are fused to tumor cells the resulting fused cells will be capable of presenting tumor antigens in an enhanced manner, thus allowing the body's immune system to recognize the tumor antigens on the cancer itself. If this occurs, the patient's immune system may be specifically stimulated, producing a clinically meaningful immune response against the tumor.

In this study DCs produced from healthy volunteer donors (allogeneic DCs) will be fused to the patient's own tumor cells (autologous tumor cells), using an electrical current. The fused dendritic/tumor cells will be returned to the patient in a series of vaccines, six weeks apart.

The purpose of this trial is to determine whether fusing autologous tumor with allogeneic DCs will, with limited associated toxicity, present tumor antigen in such a way as to stimulate an immune response and also show evidence of tumor response.

Safety/Efficacy of a Vaccine Prepared From Dendritic Cells Combined With Tumor Cells to Treat Advanced Kidney Cancer

Phase 1/2 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma

Genzyme, a Sanofi Company

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer	NCT04670445	Stage IV Melano... Advanced Lung C... Stage IV Non-Sm... Unresectable No... Unresectable St... Small Cell Lung... Stage IV Merkel... Stage IV Cutane... Stage IV Basal ... Stage IV Breast... Stage IV Colore... Stage IV Gastri... Stage IV Esopha... Stage IV Hepato... Stage IV Renal ... Stage IV Bladde... Stage IV Head a... Stage IV Cervic... Stage IV Endome... Stage IV Mesoth... Immunotherapy Immune Checkpoi...	Educational Vid... Usual Care	18 Years -	Massachusetts General Hospital
IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)	NCT00351949	Stage IV Renal ...	IMP321	18 Years -	Immutep S.A.S.
IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)	NCT00351949	Stage IV Renal ...	IMP321	18 Years -	Immutep S.A.S.
Safety/Efficacy of a Vaccine Prepared From Dendritic Cells Combined With Tumor Cells to Treat Advanced Kidney Cancer	NCT00050323	Carcinoma, Rena...	Allogeneic DCs ...	18 Years -	Sanofi

Spots Global Cancer Trial Database for stage iv renal cell carcinoma