Status:
COMPLETED
Avelumab With Chemoradiation in Locally Advanced Rectal Cancer
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 patho...
Eligibility Criteria
Inclusion
- 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
- 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 study
- Prior malignancies within 3 years of registration (with the exception of non- melanomatous skin cancer)
- Prior organ transplantation, including allogeneic stem-cell transplantation
- 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
Key Trial Info
Start Date :
April 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03299660
Start Date
April 30 2018
End Date
February 28 2023
Last Update
March 16 2023
Active Locations (7)
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1
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
2
Royal North Shore
St Leonards, New South Wales, Australia, 2065
3
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
4
Cabrini Hospital
Malvern, Victoria, Australia, 3144