# Pilot Trial of Nivolumab plus Cabozantinib for Advanced Solid Tumors in Patients with HIV infection

> **NIH NIH P30** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2020 · $125,216

## Abstract

PROJECT SUMMARY/ABSTRACT
 The tolerability and efficacy of immunotherapy (either alone or in combination treatment)
remains largely unknown in patients living with HIV on antiretrovirals (ART), who had generally
been excluded from previous trials. We recently compiled one of the largest experiences among
patients with HIV infection and lung cancer. Our data showed a remarkably low expression of PD-
L1 in this patient population. We also found that alternative immune checkpoints were widely
expressed in solid tumors. Intriguingly, the majority of PD-L1 negative lung cancers expressed
alternative immune checkpoints, implicating their potential roles in mediating immune escape
mechanisms within the tumor microenvironment, apart from the PD-1/PD-L1 axis.
 As an anti-angiogenic agent, Cabozantinib is also associated with an immune permissive
tumor environment with immune-stimulatory activities. Its antitumor activity has been observed in
thyroid cancer, renal cell and hepatocellular carcinomas, as well as Kaposi sarcoma (KS) and
other solid tumors. The combination of Cabozantinib with Nivolumab may modify the tumor
microenvironment and reverse the resistance to immunotherapy.
 In the proposed study, we will determine the safety profile and clinical benefits of the
combined treatment with Nivolumab and Cabozantinib in HIV infected patients with advanced
solid tumors (especially KS). The Primary objectives are to determine the safety of combined
Nivolumab and Cabozantinib in HIV patients with advanced solid tumors and to determine the
feasibility to deliver the combined Nivolumab and Cabozantinib (40mg daily) for a minimum of 4
cycles in at least 75% of the subjects or to achieve a confirmed objective response. Six patients
will be enrolled in the safety run-in cohort. At the expansion cohort, 12 additional subjects with
KS would be enrolled to gather more data on safety and correlative studies. We will also conduct
correlative analyses to expand our understanding of the underlying biology, predictive biomarkers
and treatment resistance in this group of patients. We expect that the combined treatment of
Nivolumab and Cabozantinib is safe and feasible in HIV patients with solid tumors. Moreover, we
anticipate that the combination has clinical activity in this unique and understudied patient
population.

## Key facts

- **NIH application ID:** 10227387
- **Project number:** 3P30CA013330-48S3
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** EDWARD CHU
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $125,216
- **Award type:** 3
- **Project period:** 1997-06-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10227387

## Citation

> US National Institutes of Health, RePORTER application 10227387, Pilot Trial of Nivolumab plus Cabozantinib for Advanced Solid Tumors in Patients with HIV infection (3P30CA013330-48S3). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10227387. Licensed CC0.

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