Avelumab With Chemoradiation in Locally Advanced Rectal Cancer (NCT03299660) | Clinical Trial Compass
CompletedPhase 2
Avelumab With Chemoradiation in Locally Advanced Rectal Cancer
Australia37 participantsStarted 2018-04-30
Plain-language summary
This trial is investigating the inclusion of avelumab post long-course chemo-radiotherapy in patients with resectable locally advanced rectal cancer. It is hypothesised that this may enhance the pathological and imaging response rates whilst potentially reducing the relapse rates. Participants will receive standard long course chemoradiotherapy (LCCRT) treatment with radiotherapy and 5-fluorouracil (5 FU)/Capecitabine for 6 weeks, this then followed by 4 cycles of Avelumab and then surgical resection. The trial will measure disease response just prior to surgery and participants will be followed up for a minimum of 18 months (from study entry) and up to 42 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female aged ≥ 18 years at screening
✓. Patients with histologically confirmed rectal adenocarcinoma clinical stage T3bN1-N2M0, T3c/dN0-N2M0, T4N0-N2M0 (see Appendix 1),1 as defined by pelvic MRI
✓. Planned to receive neoadjuvant long course chemoradiotherapy (50.4 Gy, with infusional 5FU or capecitabine) followed by curative total mesorectal excision plus abdomino-perineal resection or anterior resection
✓. Lower border of tumour must be within 12 cm from anal verge
✓. Measurable disease by RECIST1.12
✓. ECOG Performance Status 0-1
✓. Patients must be willing to provide fresh (where possible) and archival tumour tissue samples for translational studies at specified time points
✓. Adequate organ function
Exclusion criteria
✕. Patients with disease outside the pelvis
What they're measuring
1
Pathological Response rate
Timeframe: At time of resection i.e.16 -18 weeks post commencement of treatment
✕. Participation in another interventional clinical trial within 30 days of registration (participation in observational studies are permitted)
✕. Concurrent anti-cancer treatment
✕. Concurrent treatment with a non-permitted drug (Section 8.3.2)
✕. Major surgery for any reason within 4 weeks of registration (except defunctioning stoma creation with the patient having fully recovered from this procedure)
✕. Current use of immunosuppressive medication. Except for the following: (a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); (b). Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; (c). Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication); (d) Short-term administration of systemic steroids (that is, for allergic reactions or the management of irAEs) is allowed while on study.
✕. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible