Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Patients receive TTFields at 150 kHzconcomitant with atezolizumab, gemcitabine and nab-paclitaxel until disease progression or loss of clinical benefit.

The NovoTTF-200T is a portable, battery operated system intended for continuous home use, which delivers TTFields at a frequency of 150kHz to the patient by means of insulated transducer arrays. The NovoTTF-200T produces TTFields that exert electric forces intended to disrupt cancer cell division.

TTFields at 150 kHz application will be continuous for at least 18 hours a day on average. TTFields will be continued until disease progression according to RECISTv1.1 or loss of clinical benefit.

Tumor Treating Fields

Atezolizumab is a humanized IgG1 monoclonal antibody which targets human PD-L1and inhibits its interaction with its receptors, PD-1 and B7.1 (CD80). Both of these interactions are reported to provide inhibitory signals to T cells. Atezolizumab is administered as an intravenous solution.

Atezolizumab may continue until disease progression according to RECIST v1.1 or loss of clinical benefit.

Gemcitabine is a standard of care chemotherapy drug administered as an intravenous infusion.

Gemcitabine may continue until disease progression according to RECIST v1.1 or loss of clinical benefit.

Nab-paclitaxel is a standard of care chemotherapy drug administered as an intravenous infusion.

Nab-paclitaxel may continue until disease progression according to RECIST v1.1 or loss of clinical benefit.

nab-paclitaxel

John Shin, MD

Teresa Macarulla Mercade

Angela Lamarca Lete

Antonio Cubillo Gracian

Inmaculada Ales

Mariano Ponz-Sarvise

The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy.

The PANOVA-4 study is an international, multi-center, research study for female and male adult patients diagnosed with metastatic pancreatic ductal adenocarcinoma (mPDAC).

The purpose of the study is to test the efficacy and safety of TTFields, delivered using the NovoTTF-200T Treatment Kit, concomitantly with atezolizumab, gemcitabine and nab-paclitaxel as first line treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).

The chemotherapy used in this study, gemcitabine and nab-paclitaxel, are standard-of-care treatment for metastatic pancreatic cancer. The atezolizumab drug and the NovoTTF-200T device are investigational for this tumor type. Atezolizumab is an immunotherapy drug that works with the immune system to help fight cancer. NovoTTF-200T is a non-invasive medical device that delivers Tumor Treating Fields (TTFields) at 150kHz to the cancer in the abdominal region, where the tumor is located.

The study is expected to enroll 76 patients in centers around the world. The expected duration on study per patient is approximately 12 months.

Patients with previously untreated mPDAC who meet all inclusion criteria and none of the exclusion criteria as determined by the investigator will initiate study treatment within 28 days from signing the Informed Consent Form (ICF) to receive TTFields (150 kHz), atezolizumab, gemcitabine and nab-paclitaxel.

All patients enrolled in the study will receive continuous TTFields therapy concomitant with monthly atezolizumab treatments for their metastatic pancreatic cancer and weekly gemcitabine and nab-paclitaxel.

While on the study, patients will be asked to visit the clinic every 4 weeks, in order to perform a physical examination, blood tests,and some other assessments. Patients will be asked to have a radiological examination (CT scan of the chest abdomen and pelvis) every 8 weeks to assess the status of the disease.

Study treatments will continue until disease progression according to RECIST v1.1, or loss of clinical benefit.

Patients who experience disease progression will be permitted to continue study treatments if there is evidence of clinical benefit.

Subjects will return to the clinic for one final visit approximately 30 days after discontinuation of the last study treatment.

Following the final visit, the subjects will be contacted every three months by telephone to answer basic questions about their health status.

Prospective, open-label, single arm, multi-center, historical control pilot study.

EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma

PANOVA-4: Pilot, Single Arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Disease control rate (DCR) will be measured by the proportion of patients who had either stable disease (SD) for at least 16 weeks or confirmed partial response (PR) or complete response (CR) according to RECIST v1.1

Overall survival (OS) will be measured from time of treatment initiation until date of death.

Progression-free survival (PFS) will be measured as the time from treatment initiation until progression per RECIST v1.1 or death.

1 year survival rate will be measured as the percentage of patients who are alive at one year following treatment initiation .

Objective response rate (ORR) will be measured by the proportion of patients who had either complete response or partial response per RECIST v1.1 following treatment initiation.

Progression free survival at 6 months (PFS6) will be measured as the proportion of patients who are not progressive per RECIST v1.1 at 6 months following treatment initiation.

Duration of response (DOR) will be defined as the time from the first occurrence of a documented objective response (complete or partial response) to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to RECIST v1.1.

Adverse Events will be reported as incidence by body system and MedDRA term out of the number of patients who receive at least 1 day of TTFieldstreatment or one dose of atezolizumab. Based on Common Terminology Criteria for Adverse Events, CTCAE v5.0.

NovoCure GmbH

Glucocorticoids

Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

Relacorilant is supplied as capsules for oral dosing.

Relacorilant, 100 mg and 25 mg

Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Nab-paclitaxel

William Guyer, PharmD

This is a Phase 3, open-label study to evaluate the objective response rate (ORR), in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with relacorilant in combination with nab-paclitaxel, according to blinded independent central review.

Relacorilant is a small-molecule antagonist of the glucocorticoid receptor (GR). The goals of this study are to evaluate the efficacy, safety, and pharmacokinetics (PK) of relacorilant in combination with nab-paclitaxel in the treatment of metastatic pancreatic ductal adenocarcinoma.

Eligible patients are those with mPDAC who have received at least 2 prior lines of therapy for pancreatic ductal adenocarcinoma in any setting, including at least 1 prior gemcitabine-based therapy and at least 1 prior fluoropyrimidine-based therapy.

Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) as determined by the Investigator, experiencing unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death) and subsequent treatment.

Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (RELIANT)

Percentage of patients with measurable disease at baseline who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by Blinded Independent Central Review (BICR). Tumor assessment consisted of computerized tomography (CT) scan or, with Sponsor approval, magnetic resonance imaging (MRI). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters (SOD) of target lesions.

Percentage of patients with measurable disease at baseline who achieved confirmed CR or PR per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions.

To evaluate the best overall response of CR, PR, stable disease (SD), or PD per RECIST v1.1. as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.

To evaluate the duration of response as the time of objective response (CR or PR) to the time of disease progression or death, per RECIST v1.1 as assessed by BICR and the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. PD was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.

To evaluate patients disease control rate of CR, PR, or SD at 18 weeks, per RECIST v1.1 as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

To evaluate PFS as median time to disease progression per RECIST v1.1, or death, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.

To evaluate OS as median time to death by any cause.

To evaluate PFS as the percentage of patients who are progression-free at 3, 6, and 12 months per RECIST v1.1, as assessed by BICR. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.

To evaluate OS as the percentage of patients surviving at 3, 6, and 12, months.

To assess cancer antigen 19-9 (CA19-9) response at 8 and 16 weeks in patients who have elevated CA19-9 at baseline. Response was defined as ≥50% reduction in CA19-9.

To assess tumor response based on changes in fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at 6 weeks per the EORTC criteria, as assessed by BICR.

To evaluate TTP as median time to disease progression per RECIST v1.1, as assessed by the Investigator. Tumor assessment consisted of CT scan or, with Sponsor approval, MRI. Disease progression was defined as ≥20% increase in the SOD of target lesions or the appearance of one or more new lesions.

Corcept Therapeutics

Patients will be treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

Relacorilant, 100 mg and 25 mg: Relacorilant is supplied as capsules for oral dosing.

Nab-paclitaxel: Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Relacorilant With Nab-paclitaxel

Patients were treated with relacorilant, administered orally, once daily in combination with nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.

Relacorilant, 100 mg and 25 mg: Relacorilant was supplied as capsules for oral dosing.

Nab-paclitaxel: Nab-paclitaxel was administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The independent data monitoring committee found no safety issues, however the observed response rate did not meet the predefined threshold for continuing the study. The study was terminated by the Sponsor.

Medical Director

Complete response

Partial response

No response

Intent-to-Treat (ITT) Population: Patients enrolled and treated with at least 1 dose of study treatment

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

Objective Response Rate (ORR) Per Investigator Assessment

Evaluable Population: Patients in the ITT population who had at least 1 post-baseline radiographic tumor assessment

Best Overall Response (BOR)

This outcome was not analyzed because the response rate was 0%.

Duration of Response (DOR)

Disease Control Rate (DCR)

Progression-Free Survival (PFS)

Overall Survival (OS)

3 months

6 months

12 months

8 weeks

16 weeks

Patients in the ITT population who had elevated CA19-9 at Baseline

Cancer Antigen (CA)19-9

Complete metabolic response

Partial metabolic response

Stable metabolic disease

Progressive metabolic disease

Patients in the ITT Population with measurable disease at baseline by FDG-PET evaluation

Tumor Response Per European Organization for Research and Treatment of Cancer (EORTC) Criteria

Time to Progression (TTP)

Overall Study

Gastrointestinal Agents

Pancrelipase

Pancreatin

In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.

Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel

Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel

Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Concentrate for solution infusion (Liquid in Vial)

NIS793

Dextrose 5% in water (D5W) solution for infusion

Placebo

Novartis Pharmaceuticals

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

This is a randomized, double-blind, multicenter two-arm, phase III study that has two parts:

* Safety run-in part: An open-label safety run-in part will be conducted to confirm recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel. Up to approximately 10 participants will be enrolled at each dose level to achieve at least 6 evaluable participants; however, if the starting dose is not recommended and a lower dose level is tested, 10 additional participants will be enrolled. The decision to open the randomized part will be based on dose confirmation and available safety, relevant PK, and other relevant data from run-in part
* Randomized part: Enrolled participants will be randomized to the two treatment arms.

The study treatment will be administered as a 28-day treatment cycle. Participants will be treated until unacceptable toxicity, disease progression per RECIST 1.1, withdrawal of consent or any other condition of treatment discontinuation specified in the protocol.

Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped. The trial was unblinded and study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.

Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Percentage of participants with DLTs during the first cycle of treatment in the safety run-in part. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness or concomitant medication that occurs within the first cycle of treatment with NIS793 in combination with gemcitabine and nab-paclitaxel

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

Percentage of participants with AEs including changes in laboratory parameters, vital signs, body weight and cardiac assessments

Tolerability measured by the percentage of participants who have dose adjustments (interruptions or reductions) of NIS793

Tolerability measured by the dose intensity of NIS793. Dose intensity will be computed as the ratio of actual cumulative dose received and actual duration of exposure

PFS defined as the time from the date of enrollment (run-in part) or randomization (randomized part) to the date of the first documented progression based on investigator assessment and according to RECIST 1.1 or death due to any cause.

ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as per investigator assessment and according to RECIST 1.1

DCR is the proportion of participants with BOR of CR or PR or stable disease (SD) as per investigator assessment and according to RECIST 1.1

TTR is defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR.

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

Blood samples will be collected for analysis of Cmax of NIS793

Blood samples will be collected for analysis of Ctrough of NIS793

Blood samples will be collected for analysis of AUClast of NIS793

Blood samples will be collected for analysis of AUCtau of NIS793

Blood samples will be collected for analysis of Tmax of NIS793

Blood samples will be collected for analysis of NIS793 serum concentration

ADA (anti-NIS793) prevalence at baseline is defined as the proportion of participants who have an ADA positive result at baseline

ADA (anti-NIS793) incidence on treatment is defined as the proportion of participants who are treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma	NCT06390059	Metastatic Panc...	Tumor Treating ... Atezolizumab Gemcitabine nab-paclitaxel	18 Years -	NovoCure Ltd.
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma	NCT04329949	Metastatic Panc...	Relacorilant, 1... Nab-paclitaxel	18 Years -	Corcept Therapeutics
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2	NCT04935359	Metastatic Panc...	NIS793 Nab-paclitaxel Gemcitabine Placebo	18 Years -	Novartis
Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma	NCT04329949	Metastatic Panc...	Relacorilant, 1... Nab-paclitaxel	18 Years -	Corcept Therapeutics

Spots Global Cancer Trial Database for mpdac

Every month we try and update this database with for mpdac 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 mpdac

Every month we try and update this database with for mpdac 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 mpdac 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.