What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, including PD-1 inhibitors like Dostarlimab, pembrolizumab, and nivolumab, often result in side effects such as fatigue, diarrhea, rash, and immune-related adverse events like pneumonitis and colitis. Chemotherapy agents like oxaliplatin, irinotecan, and fluorouracil can cause neuropathy, neutropenia, nausea, vomiting, diarrhea, and hand-foot syndrome. These treatments can also lead to long-term side effects, including persistent neuropathy and decreased quality of life.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of colorectal cancer, particularly for cases with specific genetic markers such as microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors that have been approved for the treatment of MSI-H or dMMR metastatic colorectal cancer. These approvals are based on their ability to target the PD-1 pathway, similar to dostarlimab, which is currently being studied for its efficacy in treating stage II and III deficient mismatch repair colon cancers.

What other types of research exist?

Promising alternatives to Dostarlimab for colorectal cancer patients include pembrolizumab combined with FOLFOX (folinic acid, fluorouracil, oxaliplatin) and the combination of FOLFIRI (folinic acid, fluorouracil, irinotecan) with Durvalumab (anti-PD-L1) and Tremelimumab (anti-CTLA-4). These combinations have shown potential in clinical trials and may offer effective treatment options in 2024.

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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

Must not have

Exclusion related to obstructing tumors

Concurrent, clinically significant, active malignancies within two years of study enrollment

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing the immunotherapy drug dostarlimab in patients with Stage II and III colon cancer. The goal is to see if the drug can shrink the tumors enough to avoid surgery. Dostarlimab helps the immune system attack the cancer cells.

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.

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.

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a tumor that is blocking any organs.

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I have not had any other major cancers in the last two years.

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I have not received a live vaccine in the last 30 days.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I do not have active bleeding from colon cancer.

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I have a weak immune system or recently had treatment that lowers my immunity.

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I have had interstitial lung disease in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major Clinical Response (MCR) Rate

Secondary study objectives

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%

Sore throat

20%

Urine discoloration

20%

Pain

20%

Paresthesia

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Neutrophil count decreased

13%

Insomnia

13%

Pain in extremity

13%

Palpitations

13%

Thrush

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

Urinary retention

Obesity

Urinary frequency

Skin infection

Hematuria

Erectile dysfunction

Generalized muscle weakness

Hemorrhoidal hemorrhage

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

Oral hemorrhage

Oral pain

Osteoporosis

Papulopustular rash

Skin ulceration

Stroke

Superficial thrombophlebitis

Thyroid stimulating hormone increased

Tremor

Encephalopathy

Endocarditis infective

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy focuses on specific molecules involved in cancer growth, such as EGFR or VEGF inhibitors. Immunotherapy, including PD-1 inhibitors like Dostarlimab, enhances the body's immune response against cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. This is particularly important for colorectal cancer patients as it offers a potential treatment option for those with specific genetic profiles, such as deficient mismatch repair (dMMR) tumors, improving their chances of a better response and survival.

Monoclonal antibody therapy for solid tumors.