Immunotherapy combo shows promise against tough rectal cancers
NCT ID NCT04130854
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding an immunotherapy drug called APX005M to standard treatment helps people with advanced rectal cancer achieve a complete response (no cancer left after treatment). 58 adults with stage II or III rectal cancer at high risk took part. The goal was to see if the combination leads to better outcomes than standard therapy alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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58 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least 18 years of age. Both men and women and members of all races and ethnic groups will be included. 2. Willing and able to provide written informed consent 3. Pathologic diagnosis of rectal adenocarcinoma 4. Stage III or Stage II with at least 1 of the following high-risk features: * Distal (\<1cm from anal ring) * cT4 or within 3mm of MR fascia * Not candidate for sphincter preservation * Extramural venous invasion 5. No prior treatment for rectal adenocarcinoma 6. Eastern Cooperative Group (ECOG) performance status of 0-1. 7. Laboratory values supporting acceptable organ and marrow function within 21 days of eligibility confirmation. Defined as follows: * WBC ≥ 3,000/mL; * ANC WBC ≥ 1,500/mL; * PLT ≥ 100,000/mL; * T Bili ≤ 1.5 x upper limit of normal (ULN); * AST/ALT ≤ 2.5 x ULN; * Creatinine ≤ 1.5 times upper limit of normal or calculated creatinine clearance \> 45 mL/min per Cockcroft-Gault equation. 8. Female participants of childbearing potential (FOCBP) must have a negative serum or urine pregnancy test (per institutional standards) within 72 hours prior to the start of study drug. FOCBP must agree to use highly-effective method(s) of contraception (Appendix A) during the study and for 90 days after the last dose of study drugs. FOCBP are those who have not been surgically sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or have not been free from menses for \>1 year without an alternative medical cause. 9. Male participants must agree to use an adequate method of contraception (Appendix A) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Exclusion Criteria: 1. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT or PET 2. Prior RT to the pelvis. 3. Uncontrolled comorbid illness or condition including an active infection, congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements. 4. Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 5. Any positive history for HIV/AIDS, HTLV, hepatitis B or hepatitis C virus indicating acute or chronic infection. 6. Any active known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 7. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease. 8. Malignancy in the past 3 years that required active treatment except locally curable cancers or cancers deemed by the treating physicians to not impact the subject's survival duration. 9. Participants receiving any other investigational agent, standard antineoplastic agents, or immunosuppressive agents. 10. Known history of interstitial lung disease. 11. Received live vaccine within 6 weeks prior to randomization. 12. Psychiatric illness/social situations that would limit consenting and compliance with study requirements. 13. Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 14. Patient is not a candidate for the full treatment regimen.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
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The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
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Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can drug cocktail spare rectal cancer patients from surgery?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- MRI and microbes: a new way to predict rectal cancer outcomes?
- Can a new drug shield rectal cancer patients from Radiation's worst side effects?
- Could a Tumor's genes reveal who can skip chemo?