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NCT05723562 · CITED IN SOURCE DOCUMENTS

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-05-26

The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer * Participant has radiologically and endoscopically evaluable disease. * Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment Exclusion Criteria: * Participant has distant metastatic disease. * Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. * Participant has any history of interstitial lung disease or pneumonitis * Participant has experienced any of the following with prior immunotherapy: any imAE of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary. * Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers. * Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients. * Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: Dostarlimab
    label
    Dostarlimab monotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dostarlimab monotherapy
    description
    Dostarlimab will be administered.
    name
    Dostarlimab
    other Names
    1. JEMPERLI
    2. dostarlimab-gxly
    3. TSR-042
    4. GSK4057190
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
154
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 12 months following their post-intervention disease assessment (PIDA)
    measure
    Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
    time Frame
    18 Months
secondary Outcomes
  1. description
    cCR24 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 24 months following their post-Intervention disease assessment (PIDA)
    measure
    Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR
    time Frame
    30 Months
  2. description
    cCR36 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 36 months following their post-Intervention disease assessment (PIDA)
    measure
    Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR
    time Frame
    42 Months
  3. description
    EFS3 is defined as participants who remained alive and free of disease progression precluding surgery, local recurrence, and distant recurrence at 3 years as assessed by Investigator
    measure
    Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator
    time Frame
    3 years
  4. description
    EFS is defined as time from the date of first dose of study intervention to any of the following events: progression of disease that precludes surgery, local recurrence, distant recurrence (all as assessed by the investigator), or death due to any cause
    measure
    Event Free Survival (EFS) as assessed by Investigator
    time Frame
    Up to 74 months
  5. description
    cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 12 months following their post-intervention disease assessment (PIDA)
    measure
    Number of Participants with cCR12 as assessed by Investigator
    time Frame
    18 Months
  6. description
    cCR24 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 24 months following their post-intervention disease assessment (PIDA)
    measure
    Number of Participants with cCR24 as assessed by Investigator
    time Frame
    30 Months
  7. description
    cCR36 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 36 months following their post-intervention disease assessment (PIDA)
    measure
    Number of Participants with cCR36 as assessed by Investigator
    time Frame
    42 Months
  8. description
    ORR is defined as number of participants achieving a partial response (PR), near complete response (nCR) or complete clinical response (cCR) at PIDA or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or incomplete clinical response (iCR) (PIDA 2) as assessed by ICR
    measure
    Objective Response Rate (ORR) assessed by ICR
    time Frame
    Up to 33 Weeks
  9. description
    ORR by Investigator, defined as achieving a PR, nCR, or cCR at PIDA or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or iCR
    measure
    Objective Response Rate (ORR) as assessed by Investigator
    time Frame
    Up to 33 Weeks
  10. description
    Organ Preservation Rate defined as not undergoing Total Mesorectal Excision (TME), either as primary management or for local recurrence, and who did not have a permanent colostomy created, at any time up to 3 years
    measure
    Organ Preservation Rate
    time Frame
    3 years
  11. description
    DSS is defined as time from the date of first dose of study intervention to death due to disease
    measure
    Disease-Specific Survival (DSS)
    time Frame
    Up to 74 months
  12. description
    DSS5 is defined as the number of participants not dying due to disease under study at 5 years from the first dose of study intervention
    measure
    Disease-Specific Response at 5 years (DSS5)
    time Frame
    Up to 5 years
Full study description
brief Summary
The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        ation for Jemperli will be posted on <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><p>Efficacy was evaluated in AZUR-1 (NCT05723562), a multicenter, single-arm, open-label trial in 154 patients with previously untreated, histologically confirmed, MSI-H/dMMR, Stage II/III LARC. Patients rece
        end
        24220
        exact text
        NCT05723562
        start
        24209
      offset unit
      unicode_code_points
      source event date
      2026-10-19
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-10-20/updates/pages/fda-grants-accelerated-approval-dostarlimab-locally-advanced-rectal-cancer.html
      source file sha256
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      source kind
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      source string sha256
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      source title
      FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer

    Preserved source evidence · Not medical advice