Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03539822 · ClinicalTrials.gov registry record · Phase 1
Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
A Phase 1 study of Colorectal Cancer and Gastric Cancer, sponsored by Anwaar Saeed.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
- 2
- Study locations
NCT03539822: Recruiting Phase 1 study of Colorectal Cancer and Gastric Cancer, sponsored by Anwaar Saeed.
NCT03539822 is a Phase 1 study of Colorectal Cancer and Gastric Cancer that is actively recruiting participants, run by Anwaar Saeed. The registered enrollment target is 117 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03539822, a Phase 1 study of Colorectal Cancer and Gastric Cancer, is actively recruiting participants, sponsored by Anwaar Saeed.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.
Primary Outcome
Defined as the highest dose studied for which the observed incidence of dose limiting toxicities (DLT) is less than 33%. Determined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- DRUG Cabozantinib
- DRUG Durvalumab
- DRUG Tremelimumab
Study Locations (2)
Kansas
- University of Kansas Cancer Center - Westwood
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2018-10-22 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 1 |
What NCT03539822 shows while recruiting
NCT03539822 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cabozantinib is the first listed.
NCT03539822 reports a single indexed study location in Kansas, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03539822 about?
NCT03539822 is a clinical study titled "Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies". The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. ...
What is the current status of trial NCT03539822?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2018-10-22. Estimated completion is 2029-06-30.
What conditions does trial NCT03539822 study?
This clinical trial studies the following conditions: Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Esophageal Adenocarcinoma.
What interventions are being tested in trial NCT03539822?
The interventions under investigation include: Cabozantinib (DRUG), Durvalumab (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT03539822?
This trial is sponsored by Anwaar Saeed, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03539822 being conducted?
This trial has 2 study locations across Kansas, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03539822's enrollment target sits among peer trials
117 205th of 381 higher than 177 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
RECRUITING · Phase 1
-
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
RECRUITING · Phase 1
-
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03786692 · 117 participants · Phase 2
Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC
- NCT04479696 · 117 participants · NA
Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
- NCT04940585 · 117 participants · NA
ROSE in Sunset Park
- NCT05277558 · 117 participants
Brain Health in Youth With Normal Weight, Overweight and Obesity at Risk for Type 2 Diabetes (T2D)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI