Rectal Adenocarcinoma study: TSR-042 or Dostarlimab vs Capecitabine or
Official title Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
ClinicalTrials.gov ID: NCT04165772
What this study is testing
What is TSR-042 (Dostarlimab)?
This is an investigational medicine being studied as a potential treatment for rectal adenocarcinoma. It is designed to help the body's immune system recognize and attack cancer cells.
Also referred to as Dostarlimab.
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 study aims to see if TSR‑042, followed by standard chemo‑radiation and surgery, is effective and safe for advanced dMMR solid tumors.
- Who it's for
- Adults with locally advanced rectal adenocarcinoma that is mismatch‑repair deficient.
- What's involved
- Participants receive the study drug, then standard chemotherapy (capecitabine) plus radiation, and later surgery. They will have regular visits and medical tests to monitor progress and safety.
- 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 the trial.
- Be ≥18 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed locally advanced solid tumor (Cohorts 1 \& 2)
- Histologically confirmed endometrial cancer (Cohort 3)
You likely can't join if
- Presence of metastatic or recurrent disease
- Prior radiation therapy, chemotherapy, or surgery for tumor a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for...
- For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
- Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7...
- Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a...
See the full eligibility criteria
- Willing and able to provide written informed consent for the trial.
- Be ≥18 years of age on the date of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically confirmed locally advanced solid tumor (Cohorts 1 \& 2)
- Histologically confirmed endometrial cancer (Cohort 3)
- Solid tumors that in standard practice would be treated with neoadjuvant therapy or surgery (depending on tumor type) (Cohorts 1 \& 2)
- Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3).
- No evidence of distant metastases.
- Radiologically measurable or clinically evaluable disease
- Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.
- Negative pregnancy test done 72 hours prior to beginning treatment, for women of childbearing potential only. people of childbearing potential must be willing to use an adequate method of contraception.
- ≥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.
- Participant receiving corticosteroids may continue if their dose is stable for least 4 weeks prior to initiating protocol therapy.
- Has QTcF ≤ 450 msec, or ≤ 480 msec for participants with bundle branch block.
- Demonstrate adequate organ function as defined below within 14 days of Cycle 1, Day 1, all screening labs should be performed within 14 days of treatment initiation.
- Hematological
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin \>9 g/dL or ≥5.6 mmol/L
- Renal
- Serum creatinine OR Measured or calculated(a) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels \> 1.5 ×...
- Hepatic
- Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for people with total bilirubin levels \> 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN
- Coagulation
- International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of...
- Presence of metastatic or recurrent disease
- Prior radiation therapy, chemotherapy, or surgery for tumor a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for treatment of endometrial hyperplasia and/or endometrial cancer.
- For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
- Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.
- Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at...
- Active infection requiring systemic therapy.
- Cohort 1 \& 3: Received prior therapy with an antibody or drug specifically targeting T- cell co-stimulation or checkpoint pathways.
- Experienced ≥ Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.
- 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 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).
- Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study...
- Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study.
- Received a live vaccine within 30 days of planned start of study medication.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment. a.
- History of interstitial lung disease.
- Known hypersensitivity to TSR-042 components or excipients.
The study team makes the final eligibility decision.
Where it is enrolling
- Hartford, Connecticut, United States
- Miami, Florida, United States
- 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
- Allentown, Pennsylvania, 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, but 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?
This study is enrolling now at Hartford, Connecticut, United States; Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.