What side effects are associated with this type of intervention?

Common treatments for rectal cancer include chemotherapy, radiation therapy, and surgery. For treatments similar to Dostarlimab, which is a PD-1 inhibitor, side effects can include fatigue, rash, diarrhea, and immune-related adverse effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These immune-related side effects occur because PD-1 inhibitors enhance the immune system's activity, which can sometimes lead to it attacking normal organs and tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for rectal cancer, including chemotherapy, radiation, and surgical options. In the realm of immunotherapy, PD-1 inhibitors like pembrolizumab have been approved for use in certain types of colorectal cancers, particularly those with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). These approvals are based on the ability of PD-1 inhibitors to enhance the immune system's response against cancer cells. Dostarlimab, another PD-1 inhibitor, is currently being studied for its efficacy in untreated dMMR/MSI-H locally advanced rectal cancer, aiming to provide a non-operative management option for patients.

What other types of research exist?

Promising alternatives to Dostarlimab for rectal cancer patients include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors with established efficacy in various cancers. Additionally, combination therapies involving PD-L1 inhibitors like Atezolizumab or Durvalumab with chemotherapy or other immunotherapies (e.g., Tremelimumab) are being explored and may offer new treatment avenues. Emerging therapies targeting specific genetic mutations or utilizing novel immune-modulating agents are also under investigation and could become viable options in the near future.

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Monoclonal Antibodies

Dostarlimab for Rectal Cancer (AZUR-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called dostarlimab on patients with a specific type of rectal cancer who haven't been treated before. The goal is to see if this drug alone can treat the cancer effectively, so patients might avoid more aggressive treatments like chemotherapy, radiation, and surgery. Dostarlimab (Jemperli™) has been approved in the EU and USA for treating certain types of cancer.

Who is the study for?

This trial is for adults with Stage II to III locally advanced rectal cancer that hasn't spread and hasn't been treated yet. Their tumors must be dMMR or MSI-H. People can't join if they've had prior treatments for their cancer, certain severe reactions to immunotherapy, other recent cancers (except some skin/bladder/in situ cancers), known allergies to dostarlimab or its parts, recent organ transplants, distant metastases, active autoimmune diseases needing treatment in the last 2 years, or lung disease/pneumonitis.

What is being tested?

The study tests Dostarlimab as a solo therapy on patients with specific types of advanced rectal cancer. The aim is to see if this drug alone can effectively treat the cancer without needing chemotherapy, radiation, or surgery. Patients who respond completely will be monitored closely instead of undergoing traditional treatments.

What are the potential side effects?

Dostarlimab may cause immune-related side effects such as inflammation in various organs including the lungs (pneumonitis), skin reactions like rashes and potentially more serious conditions like Stevens-Johnson Syndrome/toxic epidermal necrolysis/DRESS syndrome; neurological issues; blood disorders; fatigue; allergic reactions; and increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)

Secondary study objectives

Disease-Specific Response at 5 years (DSS5)

Disease-Specific Survival (DSS)

Event Free Survival (EFS) as assessed by Investigator

+11 more

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%

Paresthesia

20%

Pain

20%

Sore throat

20%

Urine discoloration

20%

Delirium

20%

Cough

20%

Dizziness

20%

Lymphocyte count decreased

13%

Neutrophil count decreased

13%

Thrush

13%

Insomnia

13%

Palpitations

13%

Pain in extremity

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 infection

Hematuria

Stroke

Oral pain

Superficial thrombophlebitis

Urinary retention

Tremor

Obesity

Thyroid stimulating hormone increased

Hemorrhoidal hemorrhage

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

Erectile dysfunction

Skin ulceration

Urinary frequency

Generalized muscle weakness

Papulopustular rash

Oral hemorrhage

Osteoporosis

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

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: Dostarlimab monotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

2020

Completed Phase 3

~1760

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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

The most common treatments for rectal cancer include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, often targeting DNA replication. Radiation therapy uses high-energy rays to damage the DNA of cancer cells, leading to cell death. Immunotherapy, such as PD-1 inhibitors like Dostarlimab, works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. This is particularly relevant for rectal cancer patients with dMMR/MSI-H tumors, as these tumors are more likely to respond to immunotherapy, potentially allowing patients to avoid more invasive treatments like surgery.

Application of minimally invasive approaches to pelvic exenteration for locally advanced and locally recurrent pelvic malignancy - A narrative review of outcomes in an evolving field.Referrals and Decision-Making Considerations Involved in Selecting a Surgeon for Rectal Cancer Treatment in the Midwestern United States.