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New treatment option for Microsatellite Stable Rectal Carcinoma
Official title A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
ClinicalTrials.gov ID: NCT06843434
What this study is testing
What is Balstilimab?
Balstilimab is an investigational medicine, being studied as a potential treatment for microsatellite stable rectal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide written informed consent for trial. a. If participant is unable to provide written informed consent, the legally...
- Be ≥18 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed rectal adenocarcinoma.
- Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance...
You likely can't join if
- Recurrent rectal cancer.
- Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.
- Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
- Other invasive malignancy ≤ 2 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy...
- Active infection requiring systemic therapy.
- Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy...
See the full eligibility criteria
- Willing and able to provide written informed consent for trial. a. If participant is unable to provide written informed consent, the legally authorized representative (LAR) of the person who is being asked to...
- Be ≥18 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed rectal adenocarcinoma.
- Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3/cT4 N0 or cT(any) cN1/2.
- No evidence of distant metastases
- Radiologically measurable or clinically evaluable disease per Protocol Section 13.0.
- Tumor specimen that demonstrates intact mismatch repair enzymes by immunohistochemistry or microsatellite stability as demonstrated by NGS or PCR.
- Negative pregnancy test done within 14 days prior to beginning treatment, for women of childbearing potential only. people of childbearing potential must be willing to use an adequate method of contraception...
- Nonchildbearing potential is defined as follows (by other than medical reasons):
- ≥45 years of age and has not had menses for \>1 year
- Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal...
- Demonstrate adequate organ function as defined in the Table 6-1 below within 28 days of Cycle 1 Day 1, and all screening labs should be performed within 28 days of treatment initiation. Hematological Absolute neutrophil...
- Recurrent rectal cancer.
- Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.
- Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
- Other invasive malignancy ≤ 2 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.
- Active infection requiring systemic therapy.
- Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors...
- Known history of interstitial lung diseases/pneumonitis
- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- Known active hepatitis B (e.g., HbsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Live vaccination within 28 days prior to receiving the first dose of immunotherapy. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \ 7 days from C1D1 or \> 7 days from future cycle on study
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 180 days of enrollment, unstable angina, congestive heart failure (New York Heart...
- Known active tuberculosis.
- Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication. a. Corticosteroid use as a premedication for IV contrast...
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo...
- Prior allogeneic tissue/solid organ transplant, except for corneal transplants.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.