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PD-1 Inhibitor

Dostarlimab for Colon Cancer (NAIO Trial)

Phase 2

Recruiting

Led By Saima M Sharif, MD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy specimen for diagnosis of dMMR Colon cancer should have enough tissue for minimum 4 and max 6 maximum adjacent unstained FFPE slides (4µm each) as determined by Protocol Pathologist Dr. Anthony Snow for CD3+ and CD8+ analysis. If there is not enough tissue present in original sample, a repeat colonoscopy and biopsy may be performed; otherwise patient is not eligible.

ECOG performance status less than or equal to 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from treatment dostarlimab until study completion, up to 5 years.

Awards & highlights

NAIO Trial Summary

This trial tests a drug to treat Stage II & III colon cancer without surgery; response rate and non-operative management assessed after 18 weeks.

Who is the study for?

This trial is for adults with Stage II or III colon cancer that hasn't spread, can be surgically removed, and has a specific abnormality called dMMR. Participants must have normal organ function tests, understand the study requirements, and agree to use contraception. Those with recent major surgery, live vaccines, other cancers within two years, uncontrolled illnesses, certain infections like HIV/HBV/HCV or active autoimmune diseases are excluded.Check my eligibility

What is being tested?

The trial is testing Dostarlimab's effectiveness in shrinking colon cancer before surgery. Patients will receive up to six cycles of Dostarlimab over 18 weeks and their response will be monitored to see if they can avoid surgery.See study design

What are the potential side effects?

Dostarlimab may cause immune-related side effects such as inflammation in various organs including the lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) and skin reactions. It might also lead to infusion-related reactions.

NAIO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colon cancer biopsy has enough tissue for the required tests.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My colon cancer is at Stage II or III and can be surgically removed in one piece.

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I am 18 years old or older.

NAIO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment dostarlimab until study completion, up to 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment dostarlimab until study completion, up to 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment dostarlimab until study completion, up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major Clinical Response (MCR) Rate

Secondary outcome measures

Metastasis-Free Survival (MFS) Prior to Surgery

Overall Response Rate (ORR)

Progression-Free Survival (PFS)

Side effects data

From 2022 Phase 2 trial • 18 Patients • NCT04409002

80%

Anemia

80%

Fatigue

73%

Abdominal pain

67%

CD4 lymphocytes decreased

67%

Alkaline phosphatase increased

67%

Nausea

60%

Anorexia

60%

Constipation

53%

Platelet count decreased

53%

Hyperglycemia

47%

Thromboembolic event

47%

Weight loss

47%

Anxiety

47%

Hypoalbuminemia

40%

Vomiting

40%

Peripheral motor neuropathy

40%

Blood bilirubin increased

40%

Dyspnea

40%

Hypertension

33%

Edema limbs

33%

Abdominal distension

33%

Aortic valve disease

33%

Back pain

33%

Diarrhea

33%

Fever

33%

Hypocalcemia

33%

Sinus tachycardia

27%

Depression

27%

White blood cell decreased

27%

Chills

27%

Ascites

27%

Hyponatremia

20%

Pain

20%

Urine discoloration

20%

Paresthesia

20%

Sore throat

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Insomnia

13%

Palpitations

13%

Thrush

13%

Pain in extremity

13%

Neutrophil count decreased

13%

Confusion

13%

Dehydration

13%

Fall

13%

Cardiac troponin T increased

13%

Alanine aminotransferase increased

13%

Aspartate aminotransferase increased

13%

Bloating

13%

Dry mouth

13%

Dysphagia

13%

Dysuria

13%

Flatulence

13%

Gastroesophageal reflux disease

13%

Glucosuria

13%

Hiccups

13%

Hypercalcemia

13%

Hyperkalemia

13%

Hypokalemia

13%

Hypophosphatemia

13%

Hypothyroidism

13%

Localized edema

Skin ulceration

Oral pain

Obesity

Oral hemorrhage

Encephalopathy

Generalized muscle weakness

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Osteoporosis

Urinary retention

Papulopustular rash

Skin infection

Endocarditis infective

Erectile dysfunction

Hematuria

Stroke

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

Urinary frequency

Superficial thrombophlebitis

Tremor

Eye disorders - Other, specify

Pelvic pain

Prostatic obstruction

Pruritus

Rash acneiform

Rectal pain

Renal calculi

Reproductive system and breast disorders - Other, specify

Wheezing

Portal vein thrombosis

Vaginal dryness

Alopecia

Arthralgia

Arthritis

Bacteremia

Biliary tract infection

Blood lactate dehydrogenase increased

Buttock pain

Dry skin

Dysgeusia

Flank pain

Gastric anastomotic leak

Gastric ulcer

Gastritis

Gastrointestinal disorders - Other, specify

Gastrointestinal pain

Hyperlipidemia

Hypoglycemia

Lethargy

Memory impairment

Mucositis oral

Muscle cramp

Muscle weakness lower limb

Myocarditis

Restlessness

Scleral disorder

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Niraparib+Dostarlimab + Radiation

NAIO Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant DostarlimabExperimental Treatment1 Intervention

Participants will receive Dostarlimab 500 mg IV every 3 weeks for 9 cycles followed by 1000 mg every 6 weeks for 12 cycles until 2 years

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

447 Previous Clinical Trials

879,697 Total Patients Enrolled

Saima M Sharif, MDPrincipal InvestigatorUniversity of Iowa Holden Comprehensive Cancer Center

Saima M Sharif, MD, MSPrincipal InvestigatorUniversity of Iowa Holden Comprehensive Cancer Center

Media Library

Dostarlimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05239546 — Phase 2

Colorectal Cancer Research Study Groups: Neoadjuvant Dostarlimab

Colorectal Cancer Clinical Trial 2023: Dostarlimab Highlights & Side Effects. Trial Name: NCT05239546 — Phase 2

Dostarlimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239546 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research still enrolling participants?

"As noted on clinicaltrials.gov, this research is presently enrolling participants. The trial's listing was first published March 24th 2023 and modified for the last time that same day."

Answered by AI

What is the current patient count of this experiment?

"Correct. Details available on clinicaltrials.gov demonstrate that this medical trial, which was first posted on March 24th 2023, is actively recruiting. Approximately 25 individuals must be recruited from a single centre."

Answered by AI

What dangers might a patient face by taking Neoadjuvant Dostarlimab?

"Our analysts at Power have assessed Neoadjuvant Dostarlimab's safety to be a 2, as this is still in the Phase 2 stage of trials and there are some data points suggesting its security yet no evidence supporting efficacy."

Answered by AI

What are the expected findings of this research endeavor?

"The primary endpoint of the clinical trial is to measure Percentage Change in Viable Tumor Cells (VTC) over 18 weeks. Secondary outcomes consist of Overall Response Rate (ORR), which regards patients with RECIST disease response, Metastasis-Free Survival Prior To Surgery and Determine ORR on Neoadjuvant Dostarlimab. All participants not meeting criteria for objective responses will be considered non-responders."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

Saima Sharif 2023. "Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05239546.

All > Colon Cancer