Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

  • End date
    Apr 1, 2022
  • participants needed
  • sponsor
    Peter MacCallum Cancer Centre, Australia
Updated on 25 January 2021
measurable disease
pelvic mri
adenocarcinoma of rectum
total mesorectal excision


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.

Condition Colorectal Cancer, Rectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, rectal carcinoma
Treatment Radiotherapy, 5 fluorouracil, Avelumab, Surgical Resection, Capecitabine Pill
Clinical Study IdentifierNCT03299660
SponsorPeter MacCallum Cancer Centre, Australia
Last Modified on25 January 2021


Yes No Not Sure

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
Absolute neutrophil count 1.5 x 109/L
Platelet count 100 x 109/L
Haemoglobin 90 g/L (may have been transfused)
Creatinine 1.5 x upper normal limit OR measured creatinine clearance 50 mL/minute
Total bilirubin 1.5 x upper normal limit
AST/ALT 2.5 x upper normal limit
Female patients of childbearing potential must have a negative urine or serum pregnancy test at screening
Both male and female patients should be willing to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) if the risk of conception exists
Has provided written informed consent for the trial
Agrees to comply with trial therapy or trial-related investigations and evaluations

Exclusion Criteria

Patients with disease outside the pelvis
Prior pelvic radiotherapy
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
Note: Patients receiving bisphosphonate or denosumab are eligible
\. 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
\. Active or history of immunodeficiencies
\. Has received prior therapy with an anti-PD1, anti-PDL1, anti-PDL2 or
anti-CTLA-4 agents
\. Has clinically significant (that is, active) cardiovascular disease
cerebral vascular accident / stroke (< 6 months prior to registration)
myocardial infarction (< 6 months prior to registration), unstable angina
congestive heart failure (New York Heart Association Classification Class II)
or serious cardiac arrhythmia requiring medication
\. Has an active infection requiring systemic therapy
\. Other severe acute or chronic medical conditions including immune
colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or
psychiatric conditions including recent (within the past year) or active
suicidal ideation or behaviour; or laboratory abnormalities that may increase
the risk associated with study participation or study treatment administration
or may interfere with the interpretation of study results and, in the judgment
of the investigator, would make the patient inappropriate for entry into this
\. Prior malignancies within 3 years of registration (with the exception of
nonmelanomatous skin cancer)
\. Prior organ transplantation, including allogeneic stem-cell
\. A known history of testing positive for HIV or known acquired
immunodeficiency syndrome (AIDS)
\. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
(positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test
is positive)
\. Known prior severe hypersensitivity to investigational product or any
component in its formulations, including known severe hypersensitivity
reactions to monoclonal antibodies (CTCAE v4.03 grade 3)
\. Is pregnant or lactating
\. Vaccination within 4 weeks of registration and while on trials is
prohibited except for administration of inactivated vaccines
\. Known deficiency of dihydropyrimidine dehydrogenase
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