Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Bevacizumab

Leucovorin

Fluorouracil

Levoleucovorin

Immunomodulating Agents

Oxaliplatin

Folic Acid

Spartalizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Folinic Acid

Folate

Vitamin B9

PDR001

bevacizumab

Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)

mFOLFOX6

Novartis Pharmaceuticals

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

The study was terminated early due to company decision.

Phase Ib study, safety run-in (N=\~6 pts) followed with an expansion (N=\~86 pts). One single arm: PDR001 in combination with bevacizumab and mFOLFOX6

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

ElevatION: CRC-101: A Phase Ib Study of PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

RECIST v1.1 = Response Evaluation Criteria in Solid Tumors v1.1

Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.

100 mg lyophilisate in vial received 400 mg every 4 weeks

spartalizumab (PDR001)

120 mg once daily first 21 days of each 28-day cycle (=4 weeks)

regorafenib

This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.

Phase 1b study, dose escalation (N=\~12). One single arm: PDR001 in combination with regorafenib

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer

A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.

Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.

Severity including dose interruptions and reductions.

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Skin Diseases

Anti-Infective Agents

Oxytetracycline

Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch.

Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing

A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.

MMS + Autologous patch

Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)

MMS and secondary intention healing

Katrine E Karmisholt, MD, PhD

Anna A Harager, Bsc

Katrine E Karmisholt, Ph.D.

Anna A Harager

The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.

Blinded photo assesment of wound healing by two independent trained clinical doctors.

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial

Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.

Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no.

Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control.

The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points.

Swab test for microbiome analysis will be conducted at day 1 and day 11-13.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer	NCT03176264	Metastatic Colo...	PDR001 bevacizumab mFOLFOX6	18 Years -	Novartis
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer	NCT03081494	Metastatic Colo...	spartalizumab (... regorafenib	18 Years -	Novartis
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery	NCT05170035	Skin Cancer Basal Cell Carc...	MMS + Autologou... MMS and seconda...	18 Years - 100 Years	Bispebjerg Hospital
Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery	NCT05170035	Skin Cancer Basal Cell Carc...	MMS + Autologou... MMS and seconda...	18 Years - 100 Years	Bispebjerg Hospital

Spots Global Cancer Trial Database for mms

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

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