Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Dostarlimab

Combination drug

Robin Patterson, RN

Amanda Fletcher, RN

Ari VanderWalde, MD, MPH

Nibedita Chakraborty

Gregory Vidal, MD

This is an open-label, single-arm, Phase 2 study which will evaluate the efficacy and safety of niraparib and dostarlimab (TSR-042) combination in patients with metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic homologous recombination deficiency (HRD) gene mutation

Niraparib and Dostarlimab in HRD Solid Tumors

A Phase II Trial of Niraparib and Dostarlimab Combination Therapy in Patients With Somatic Homologous Recombination Deficient Advanced or Metastatic Cancer

defined as the percentage of patients with CR or PR, as assessed by RECIST v.1.1 criteria using investigator review.

defined as the percentage of patients with CR, PR or SD, as assessed by RECIST v.1.1 criteria using investigator's review at 16 weeks

West Cancer Center

Principal Investigator

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

Hematinics

Vitamins

Antibodies

Irinotecan

Fluorouracil

Oxaliplatin

Folic Acid

Immunoglobulins

Vitamin B Complex

Folfirinox

Folinic Acid

Folate

Vitamin B9

Treatment with modified-FOLFIRINOX Folic acid 400mg/m\^2, 5- fluorouracil 2400mg/m\^2 for 46h, irinotecan 135mg/m\^2 and oxaliplatin 68mg/m\^2

Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m\^2, 5- fluorouracil 2400mg/m\^2 for 46h, irinotecan 135mg/m\^2 and oxaliplatin 68mg/m\^2, Anti-PD-1 antibody 200mg.

Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly

Chemotherapy

The prognosis of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with metastatic pancreatic cancer.

Metastatic pancreatic cancer patients will be enrolled in this trial. Investigators will assign patients to the treatment after randomization. The primary endpoint is overall survival. Response rate, progression-free survival, drugs related side effects and other endpoints events will be recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with metastatic pancreatic cancer.

Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer

Comparison of Therapeutic Effect Between Combination of Anti-PD-1 Antibody With mFOLFIRINOX and mFOLFIRINOX Alone in Metastatic Pancreatic Cancer Patients: A Randomized Clinical Trial

The period from the first study treatment to any cause of death

The number of cases received surgery / the total number of evaluable cases (%)

The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)

The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%)

The period from the first treatment to the first evaluation of PD or any cause of death

Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.

Zhejiang University

Proffessor

Recurrence

Rectal Neoplasms

Disease Attributes

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Capecitabine

Leucovorin

Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery

Neoadjuvant chemoradiotherapy followed by surgery

Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles.

If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI.

Concomitant chemotherapy agent: capecitabine

Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy.

Chemoradiotherapy

Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon.

Intraoperative radiotherapy is optional.

Surgery locally recurrent rectal cancer

Stefi Nordkamp, MD

Floor Piqeur, MD

Gabrielle van Ramshorst, MD, PhD

Miranda Kusters, MD, PhD

Arend Aalbers, MD, PhD

Pim Burger, MD, PhD

Klaas Havenga, MD, PhD

Fabian Holman, Md, PhD

Andreas Marinelli, MD, PhD

Jarno Melenhorst, MD, PhD

Cornelis Verhoef, MD, PhD

Marianne Guren, MD, PhD

João Maciel, MD, PhD

Eva Angenete, MD, PhD

Sofia Heyman, MD, PhD

Pamela Buchwald, MD, PhD

Henrik Iversen, MD, PhD

Pim Burger, MD

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

Induction Chemotherapy for Locally Recurrent Rectal Cancer

Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II

Participant-level datasets and statistical codes will become available upon reasonable request after the results of the study have been published.

A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin \> 0mm)

Adverse events grade 3 or higher according to the NCI-CTCAE v5.0

including data on intra-operative radiotherapy

Catharina Ziekenhuis Eindhoven

MD, PhD

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Lung Neoplasms

Carcinoma, Adenoid Cystic

Small Cell Lung Cancer

Transitional Cell Carcinoma

Adenoid Cystic Carcinoma

Mitogens

Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.

Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.

Rogaratinib (BAY1163877)

Any other drug specified in the protocol of the completed Bayer clinical trials that is used in combination with rogaratinib. Not all patients receive combination therapy.

The purpose of this study is to enable patients, who are currently receiving rogaratinib in a Bayer-sponsored clinical trial (incl. NCT01976741), to continue treatment after their respective study has been closed. Another aim is to learn if rogaratinib is safe and how it affects the body.

Rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. The drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (FGFR) that are needed for the survival of the cancer cells.

The primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug.

The secondary objective is to investigate the tolerability of rogaratinib.

Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Niraparib and Dostarlimab in HRD Solid Tumors	NCT04983745	Homologous Reco...	Combination dru...	- 100 Years	West Cancer Center
Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer	NCT03977272	Pancreatic Canc...	Combination dru... Chemotherapy	18 Years - 75 Years	Zhejiang University
Induction Chemotherapy for Locally Recurrent Rectal Cancer	NCT04389086	Recurrent Recta...	Combination dru... Chemoradiothera... Surgery locally...	18 Years -	Catharina Ziekenhuis Eindhoven
Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety	NCT04125693	Cancer	Rogaratinib (BA... Combination dru...	18 Years -	Bayer
Combination of Anti-PD-1 Antibody and Chemotherapy in Metastatic Pancreatic Cancer	NCT03977272	Pancreatic Canc...	Combination dru... Chemotherapy	18 Years - 75 Years	Zhejiang University
Induction Chemotherapy for Locally Recurrent Rectal Cancer	NCT04389086	Recurrent Recta...	Combination dru... Chemoradiothera... Surgery locally...	18 Years -	Catharina Ziekenhuis Eindhoven

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