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CTRI Number  CTRI/2025/07/090631 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A phase II clinical trial testing a cancer medicine called Nivolumab in patients with locally advanced rectal cancer. The goal is to see if a low dose (40 mg) of this medicine can help shrink the tumor before surgery, reducing the need for chemotherapy and radiation. 
Scientific Title of Study   A Phase II Single-Arm Trial to Evaluate the Efficacy of Low-Dose Nivolumab (40 mg) as Neoadjuvant Treatment in MSI-High Locally Advanced Rectal Cancer (LARgE CLOuD) 
Trial Acronym  (LARgE CLOuD) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikas Ostwal  
Designation  Professor and Consultant Medical Oncologist  
Affiliation  Tata Memorial Hospital, Mumbai  
Address  Room number 1102,Department of Medical Oncology GI, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9702288801  
Fax    
Email  dr.vikas.ostwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Ostwal  
Designation  Professor and Consultant Medical Oncologist  
Affiliation  Tata Memorial Hospital, Mumbai  
Address  Room number 1102,Department of Medical Oncology GI, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9702288801  
Fax    
Email  dr.vikas.ostwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vikas Ostwal  
Designation  Professor and Consultant Medical Oncologist  
Affiliation  Tata Memorial Hospital, Mumbai  
Address  Room number 1102,Department of Medical Oncology GI, 11th Floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9702288801  
Fax    
Email  dr.vikas.ostwal@gmail.com  
 
Source of Monetary or Material Support  
We will request for Drug support and extramural grant from pharma companies and we will request for intramural fund from Tata Memorial Hospital, Dr Ernest Borges Road, Parel Mumbai 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai Maharashtra India 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Ostwal   Tata Memorial Hospital   OPD 319, Dept of GI Medical Oncology, 3rd floor,Homi Bhabha Building, Tata Memorial Hospital, Dr Ernest Borges Road,Parel, Mumbai 400012 Mumbai MAHARASHTRA Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9702288801

dr.vikas.ostwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low-dose nivolumab 40 mg  Low-dose nivolumab 40 mg IV in 100 ml NS over 1hr (IV line with low-protein binding 0.2 or 0.22-micron in-line filter) administered intravenously every 2 weeks for 6 months. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Subjects must have histologically confirmed MSI-H locally advanced rectal cancer
2.Male or female subjects aged more than or equal to 18 years.
3.Patients who have not received any treatment for rectal cancer.
4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0–1.
5.Subjects must have normal organ and marrow function.
6.Patients with HIV are potentially eligible, as long as they have a CD4 count more than 200, are on concurrent HAART (highly active antiretroviral therapy), and have no active AIDS-defining conditions.
7.Negative serum or urine pregnancy test at screening for women of childbearing potential.
8.Contraception.
9.Both men and women of all races and ethnic groups are eligible for this study.
10.Willing and able to comply with all study requirements, including treatment and regular follow-up assessments.
11.Ability to understand and willingness to sign a written informed consent document. 
 
ExclusionCriteria 
Details  1.Patients with metastases
2.Previously treated rectal cancer patients
3.Patients on other investigational agents
4.Chemotherapy within 3 weeks
5.Current use of immunosuppressants except low-dose steroids or specific short-term uses
6.Active autoimmune disease requiring immunosuppressants
7.Prior organ or stem cell transplant
8.Active infection needing systemic treatment
9.Active hepatitis B or C
10.Vaccination within 4 weeks before or during study (except inactivated vaccines)
11.Severe hypersensitivity to study drug or monoclonal antibodies
12.Significant cardiovascular disease (stroke, MI, heart failure, arrhythmia within 6 months)
13.Unresolved toxicity from prior therapy unless mild and not risky
14.Severe medical or psychiatric conditions or abnormal labs that increase study risk
15.Pregnant women excluded; effective contraception required
16.Breastfeeding not allowed during and for 1 month after treatment
17.No prior immunotherapy use 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary objective: To evaluate the clinical complete response (cCR) rate of low-dose nivolumab (40 mg) as neoadjuvant therapy in MSI-H locally advanced rectal cancer.

cCR can be defined as no evidence of active disease as per rectal examination, sigmoidoscopy and radiological evaluation 		 every 2 months upto 3 years
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Pathological complete response (pCR) rate in patients undergoing surgery.
2.Disease -free survival (PFS) in patients undergoing surgery..
3.progression -free survival (PFS) in patients not undergoing surgery
4.Overall survival (OS) in patients undergoing surgery.
5.Safety & toxicity profile in patients undergoing surgery.
6.Quality of life (QoL) assessment in patients undergoing surgery. 		 every 2 months upto 3 years 
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   21/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study is led by Dr. Vikas Ostwal and a team of doctors at Tata Memorial Hospital, Mumbai. This study will be conducted in Tata Memorial Centre, Mumbai.

This study is testing a cancer medicine called Nivolumab in patients with locally advanced rectal cancer. The goal is to see if a low dose (40 mg) of this medicine can help shrink the tumor before surgery, reducing the need for chemotherapy and radiation.

Most rectal cancer patients get chemotherapy and radiation before surgery, but this can have many side effects like bowel and bladder problems. Some rectal cancers, especially those with a specific genetic feature (MSI-High), may respond better to immunotherapy instead. This study is testing a lower dose of Nivolumab to make treatment more affordable, effective, and safer.

  • 53 patients will receive low-dose Nivolumab (40 mg) through an IV every 2 weeks for 6 monthly
  • After treatment, doctors will check if the cancer has completely disappeared (called clinical complete response or cCR).
  • If the tumor is gone, patients will be closely monitored instead of having immediate surgery (a "watch-and-wait" approach).
  • If the tumor is still present, patients will receive standard chemotherapy and surgery.

The main goals of the study are :

  1. To check how many patients achieve a complete response after Nivolumab treatment.
  2. To evaluate how long patients remain cancer-free (progression-free survival and overall survival).
  3. To monitor side effects and safety of the low-dose treatment.
  4. To assess patients’ quality of life during and after treatment.

 

Who can participate?

  • Adults (18+ years) with MSI-High rectal cancer that has not been treated before.
  • Patients in good overall health, with normal organ function.
  • Women of childbearing age must use contraception during treatment.

 

Who cannot participate?

  • Patients who already had treatment for rectal cancer.
  • Patients with spreading (metastatic) cancer.
  • Patients with severe medical conditions or active infections like Hepatitis or HIV.
  • Pregnant or breastfeeding women.

What are the benefits of this study?

  • If successful, patients may avoid surgery and chemotherapy while still being cancer-free.
  • Low-dose treatment reduces costs and side effects, making it more accessible.
  • This research can improve cancer care worldwide, especially in resource-limited countries.

 

How long will the study last?

The study will run for 4 years, with regular check-ups and follow-ups.

 

Are there any risks?

Nivolumab can cause immune-related side effects like skin rash, fatigue, diarrhea, or changes in hormone levels. These will be closely monitored during the study.

What will be provided to patients?

  • Free Nivolumab treatment and necessary tests.
  • Financial support for travel expenses.
  • Patients must cover the cost of surgery if needed.

Conclusion

This study aims to prove that low-dose Nivolumab can effectively treat rectal cancer while reducing costs and side effects. If successful, it may change how rectal cancer is treated, offering a less aggressive but equally effective approach.


 
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