Breast Cancer

(Arm A) Avelumab + Proto Pump Inhibitor (PPI)

Avelumab

Aspirin

Lansoprazole

A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

1. Mean combined gene expression of COX-2 tumour-promoting genes, in samples taken post treatment

Post treatment tumour infiltrating lymphocytes (TIL) assessed by IHC using standardised methodology (Salgado et al., 2015)

Mean combined gene expression of the cancer-inhibitory elements of the COX-2 inflammatory signature, in samples taken post treatment

The post treatment COX-2 inflammatory signature

Safety and tolerability assessed by grade 3-4 AEs and SAEs. In addition, grade 2 renal toxicity AEs (creatinine rise) and grade 2 gastrointestinal toxicity AEs (duodenal perforation, dyspepsia, oesophageal haemorrhage, dysphagia, oesophageal pain, oesophageal perforation, oesophagitis)

Rachel Cox

Project Manager

The Christie NHS Foundation Trust

University of Manchester

Patients will be randomly assigned to one of two arms:-
21 patients into Arm A: Avelumab + Proton Pump Inhibitor (PPI)
21 patients into Arm B: Avelumab + Aspirin + PPI

Laboratory staff and the unblinded statistician ill remain blinded to trial treatment

Colourless odourless aqueous solution for infusion at dose of 10mg/kg

Lansoprazole (Proton Pump Inhibitor)

A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

Mean combined gene expression of COX-2 tumour-promoting genes, in samples taken post treatment

Mean combined gene expression of the elements of the denominator of the COX-2 ratio, in samples taken post treatment.

The post treatment COX-2 ratio (a ratio of mean expression of 9 tumour-promoting to 15 tumour-inhibitory genes)

Safety and tolerability assessed by grade 3-4 AEs and SAEs. In addition, grade 2 renal toxicity AEs (creatinine rise) and grade 2 gastrointestinal toxicity AEs (duodenal perforation, dyspepsia, oesophageal haemorrhage, dysphagia, oesophageal pain, oesophageal perforation, oesophagitis).

Non CI _Project manager

Laboratory staff and the blinded statistician will remain blinded to trial treatment arm

Melanoma Stage III or IV

No Prior Chemotherapy

Sorafenib: 2x400 mg daily PO (2 tablets (200 mg each) each AM and PM). DAY 1-56.
DTIC: 1-hour IV infusion 1000mg/m2 DAY 14 and 42.

melanoma/kalium

A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

Monocentric Pilot Study Investigating the Metabolic Activity of Melanoma in Vivo During Sorafenib and Dacarbazine

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